AVAHO

Colorectal cancer (CRC) survivor rates are improving, which means people are living long enough after the cancer to have other chronic conditions. CRC is the third most commonly diagnosed cancer among users of the US Department of Veterans Affairs (VA) health care system, according to VA researchers, and there is a high prevalence of cardiovascular disease (CVD). The researchers also say emerging evidence suggests that survivors of CRC may be more likely to develop diabetes mellitus (DM) in the 5 years following their cancer diagnosis. But they add that there is a paucity of research about control of CVD-related chronic conditions among survivors of CRC.

In a retrospective study, the researchers compared 9,758 nonmetastatic patients with CRC with 29,066 people who had not had cancer. At baseline, 69% of the survivors of CRC and the matched controls were diagnosed with hypertension, 52% with hyperlipidemia, and 37% with DM.

But somewhat contrary to expectations, the researchers found no significant differences between the 2 groups for DM in the year following the baseline assessment. The researchers point to the VA’s “strong history” of DM risk reduction research and 2 national programs targeting DM, although they do not know whether the people in their study participated in those.

The survivors of CRC also had half the odds of being diagnosed with hyperlipidemia. However, they did have 57% higher odds of being diagnosed with hypertension.

Although the researchers acknowledge that hypertension is a transient adverse effect of certain chemotherapy regimens, they found only 7 survivors of CRC and 11 controls were treated with bevacizumab during their first year postanchor date.

The relationship between nonmetastatic CRC and CVD risk-related chronic conditions is complex, the researchers say. But they share risk factors, including obesity, physical inactivity, and diet.

The researchers call behavioral change interventions that improve survivors of CRC physical activity, dietary habits, and body mass index a “promising beginning” but call for other similar interventions, particularly those targeting blood pressure management and adherence to antihypertensive medications (which was significantly lower among the survivors).

While the magnitude of the effect regarding hypertension seems relatively small, the researchers say, they believe it is still an important difference when considered from a population health perspective—and one that should be addressed. The researchers also note that nonmetastatic survivors of CRC and controls had very similar rates of primary care visits in the 3 years postanchor date and as a result similar opportunities to receive a hypertension diagnosis.

Colorectal cancer (CRC) survivor rates are improving, which means people are living long enough after the cancer to have other chronic conditions. CRC is the third most commonly diagnosed cancer among users of the US Department of Veterans Affairs (VA) health care system, according to VA researchers, and there is a high prevalence of cardiovascular disease (CVD). The researchers also say emerging evidence suggests that survivors of CRC may be more likely to develop diabetes mellitus (DM) in the 5 years following their cancer diagnosis. But they add that there is a paucity of research about control of CVD-related chronic conditions among survivors of CRC.

In a retrospective study, the researchers compared 9,758 nonmetastatic patients with CRC with 29,066 people who had not had cancer. At baseline, 69% of the survivors of CRC and the matched controls were diagnosed with hypertension, 52% with hyperlipidemia, and 37% with DM.

But somewhat contrary to expectations, the researchers found no significant differences between the 2 groups for DM in the year following the baseline assessment. The researchers point to the VA’s “strong history” of DM risk reduction research and 2 national programs targeting DM, although they do not know whether the people in their study participated in those.

The survivors of CRC also had half the odds of being diagnosed with hyperlipidemia. However, they did have 57% higher odds of being diagnosed with hypertension.

Although the researchers acknowledge that hypertension is a transient adverse effect of certain chemotherapy regimens, they found only 7 survivors of CRC and 11 controls were treated with bevacizumab during their first year postanchor date.

The relationship between nonmetastatic CRC and CVD risk-related chronic conditions is complex, the researchers say. But they share risk factors, including obesity, physical inactivity, and diet.

The researchers call behavioral change interventions that improve survivors of CRC physical activity, dietary habits, and body mass index a “promising beginning” but call for other similar interventions, particularly those targeting blood pressure management and adherence to antihypertensive medications (which was significantly lower among the survivors).

While the magnitude of the effect regarding hypertension seems relatively small, the researchers say, they believe it is still an important difference when considered from a population health perspective—and one that should be addressed. The researchers also note that nonmetastatic survivors of CRC and controls had very similar rates of primary care visits in the 3 years postanchor date and as a result similar opportunities to receive a hypertension diagnosis.

Colorectal cancer (CRC) survivor rates are improving, which means people are living long enough after the cancer to have other chronic conditions. CRC is the third most commonly diagnosed cancer among users of the US Department of Veterans Affairs (VA) health care system, according to VA researchers, and there is a high prevalence of cardiovascular disease (CVD). The researchers also say emerging evidence suggests that survivors of CRC may be more likely to develop diabetes mellitus (DM) in the 5 years following their cancer diagnosis. But they add that there is a paucity of research about control of CVD-related chronic conditions among survivors of CRC.

In a retrospective study, the researchers compared 9,758 nonmetastatic patients with CRC with 29,066 people who had not had cancer. At baseline, 69% of the survivors of CRC and the matched controls were diagnosed with hypertension, 52% with hyperlipidemia, and 37% with DM.

But somewhat contrary to expectations, the researchers found no significant differences between the 2 groups for DM in the year following the baseline assessment. The researchers point to the VA’s “strong history” of DM risk reduction research and 2 national programs targeting DM, although they do not know whether the people in their study participated in those.

The survivors of CRC also had half the odds of being diagnosed with hyperlipidemia. However, they did have 57% higher odds of being diagnosed with hypertension.

Although the researchers acknowledge that hypertension is a transient adverse effect of certain chemotherapy regimens, they found only 7 survivors of CRC and 11 controls were treated with bevacizumab during their first year postanchor date.

The relationship between nonmetastatic CRC and CVD risk-related chronic conditions is complex, the researchers say. But they share risk factors, including obesity, physical inactivity, and diet.

The researchers call behavioral change interventions that improve survivors of CRC physical activity, dietary habits, and body mass index a “promising beginning” but call for other similar interventions, particularly those targeting blood pressure management and adherence to antihypertensive medications (which was significantly lower among the survivors).

While the magnitude of the effect regarding hypertension seems relatively small, the researchers say, they believe it is still an important difference when considered from a population health perspective—and one that should be addressed. The researchers also note that nonmetastatic survivors of CRC and controls had very similar rates of primary care visits in the 3 years postanchor date and as a result similar opportunities to receive a hypertension diagnosis.

Providing access to clinical trials for veteran and active-duty military patients can be a challenge, but a significant number of trials are now recruiting patients from those patient populations. Many trials explicitly recruit patients from the VA, the military, and IHS. The VA Office of Research and Development alone sponsors or cosponsors nearly 1,000 research initiatives, and many more are sponsored by Walter Reed National Medical Center and other major defense and VA facilities. The clinical trials listed below are all open as of August 1, 201 8 ; have at least 1 VA, DoD, or IHS location recruiting patients; and are focused on treatment for colorectal cancer. For additional information and full inclusion/exclusion criteria, please consult clinicaltrials.gov.

Lung-MAP (multiple trials)

Lung-MAP (SWOG S1400) is a multidrug, multi-substudy, biomarker-driven squamous cell lung cancer clinical trial that uses state-of-the-art genomic profiling to match patients to substudies testing investigational treatments that may target the genomic alterations, or mutations, found to be driving the growth of their cancer.

ID: NCT02154490, NCT02595944, NCT02766335, NCT02785913, NCT02785939, NCT02926638, NCT02965378, NCT03373760, NCT03377556
Sponsor: Southwest Oncology Group
Locations: VA Connecticut Healthcare System-West Haven Campus; Hines VA Hospital, Illinois; Richard L. Roudebush VAMC, Indianapolis, Indiana; Ann Arbor VAMC, Michigan; Kansas City VAMC, Missouri; VA New Jersey Health Care System, East Orange; Michael E. DeBakey VAMC Houston, Texas

ALCHEMIST: Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trials (multiple trials)

A group of randomized clinical trials for patients with early-stage non-small cell lung cancer whose tumors have been completely removed by surgery.

ID: NCT02193282, NCT02194738, NCT02201992, NCT02595944
Sponsor: National Cancer Institute
Locations: Little Rock VAMC, Arkansas; VA Connecticut Healthcare System West Haven Campus; Atlanta VAMC, Decatur, Georgia; Hines VA Hospital, Illinois; Richard L. Roudebush VAMC, Indianapolis, Indiana; Minneapolis VAMC, Minnesota; Saint Louis VAMC, Missouri; Veterans Affairs New York Harbor Healthcare System-Brooklyn Campus; Dayton VAMC, Ohio; William S. Middleton VAMC, Madison, Wisconsin

Veterans Affairs Lung Cancer Or Stereotactic Radiotherapy (VALOR)

The standard of care for stage I non-small cell lung cancer has historically been surgical resection in patients who are medically fit to tolerate an operation. Recent data now suggests that stereotactic radiotherapy may be a suitable alternative. This includes the results from a pooled analysis of two incomplete phase III studies that reported a 15% overall survival advantage with stereotactic radiotherapy at 3 years. While these data are promising, the median follow-up period was short, the results underpowered, and the findings were in contradiction to multiple retrospective studies that demonstrate the outcomes with surgery are likely equal or superior. Therefore, the herein trial aims to evaluate these two treatments in a prospective randomized fashion with a goal to compare the overall survival beyond 5 years. It has been designed to enroll patients who have a long life-expectancy, and are fit enough to tolerate an anatomic pulmonary resection with intraoperative lymph node sampling.

ID: NCT02984761
Sponsor: VA Office of Research and Development
Locations: Edward Hines Jr. VA Hospital, Hines, Illinois; Richard L. Roudebush VA Medical Center, Indianapolis, Indiana; Minneapolis VA Health Care System, Minnesota; Durham VAMC, North Carolina; Michael E. DeBakey VAMC, Houston, Texas; Hunter Holmes McGuire VA Medical Center, Richmond, Virginia

Naloxegol in Treating Patients With Stage IIIB-IV Non-Small Cell Lung Cancer

This randomized pilot clinical trial studies the side effects and best dose of naloxegol and to see how well it works in treating patients with stage IIIB-IV non-small cell lung cancer. Naloxegol may relieve some of the side effects of opioid pain medication and fight off future growth in the cancer.

ID: NCT03087708
Sponsor: Alliance for Clinical Trials in Oncology
Locations: Minneapolis VAMC, Minnesota; Kansas City VAMC, Missouri; VA Western New York Health Care System-Buffalo; Salisbury VAMC, North Carolina

Palliative Care Interventions for Outpatients Newly Diagnosed With Lung Cancer: Phase II (PCI2)

The focus of the study is to test a nurse-led telephone-based palliative care intervention on improving the delivery of care for patients with newly diagnosed lung cancer. The study is a three site randomized control trial to determine the efficacy of the intervention on improving patients’ quality of life, symptom burden, and satisfaction of care. Additionally, the study will test an innovative care delivery model to improve patients’ access to palliative care. The investigators will also determine the effect of the intervention on patient activation to discuss treatment preferences with their clinician and on clinician knowledge of patients’ goals of care.

ID: NCT03007953
Sponsor: VA Office of Research and Development
Locations: Birmingham VAMC, Alabama; VA Portland Health Care System, Oregon; VA Puget Sound Health Care System Seattle Division, Washington

Radiation Therapy Regimens in Treating Patients With Limited-Stage Small Cell Lung Cancer Receiving Cisplatin and Etoposide

Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as etoposide, carboplatin and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known which radiation therapy regimen is more effective when given together with chemotherapy in treating patients with limited-stage small cell lung cancer. This randomized phase III trial is comparing different chest radiation therapy regimens to see how well they work in treating patients with limited-stage small cell lung cancer.

ID: NCT00632853
Sponsor: Alliance for Clinical Trials in Oncology
Locations: Baltimore VAMC, Maryland; Kansas City VAMC, Missouri; VA Western New York Health Care System, Buffalo, New York; Dayton VAMC, Ohio; Zablocki VAMC, Milwaukee, Wisconsin

Comparison of Different Types of Surgery in Treating Patients With Stage IA Non-Small Cell Lung Cancer

Wedge resection or segmentectomy may be less invasive types of surgery than lobectomy for non-small cell lung cancer and may have fewer side effects and improve recovery. It is not yet known whether wedge resection or segmentectomy are more effective than lobectomy in treating stage IA non-small cell lung cancer.

ID: NCT00499330
Sponsor: Alliance for Clinical Trials in Oncology
Locations: VA Loma Linda Healthcare System, California; VA Long Beach Medical Center, California; Richard L. Roudebush VAMC, Indianapolis, Indiana; Portland VAMC, Oregon

Lung Cancer Screening Decisions (VA-LCSDecTool)

Veterans have a high risk of developing lung in comparison to general populations due to their older age and smoking history. Recent evidence indicates that lung cancer screening with low dose CT scan reduces lung cancer mortality among older heavy smokers. However, the rates of false positive findings are high, requiring further testing and evaluation. Preliminary studies report that while some Veterans are enthusiastic about screening, others are highly reluctant. Patient preferences should be considered as part of an informed decision making process for this emerging paradigm of lung cancer control. Effective methods for preference assessment among Veterans have not yet been developed, evaluated, and integrated into clinical practice. The specific aims of this study are to 1) elicit patient and provider stakeholder input to inform the development of a lung cancer screening decision tool, 2) develop a web based Lung Cancer Screening Decision Tool (LCSDecTool) that incorporates patient and provider input, and 3) evaluate the impact of the LCSDecTool compared to usual care on the decision process, clinical outcomes, and quality of life.

ID: NCT02899754
Sponsor: VA Office of Research and Development
Locations: VA Connecticut Healthcare System West Haven Campus; Corporal Michael J. Crescenz VAMC Philadelphia, Pennsylvania

Molecular Predictors of Cancer in Patients at High Risk of Lung Cancer

Using samples of blood, urine, sputum, and lung tissue from patients at high risk of cancer for laboratory studies may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.

ID: NCT00898313
Sponsor: Vanderbilt-Ingram Cancer Center
Location: VAMC Nashville, Tennessee

Improving Supportive Care for Patients With Thoracic Malignancies

The purpose of this study is to use a proactive approach to improve symptom management of patients with thoracic malignancies. In this pilot study, the investigators propose to evaluate the feasibility of using outbound, proactive telephone symptom assessment strategies and measure the efficacy of this approach on patient satisfaction with their care, patient activation, quality of life and use of healthcare resources.

ID: NCT03216109
Sponsor: Palo Alto Veterans Institute for Research
Location: VA Palo Alto Health Care System, California

Providing access to clinical trials for veteran and active-duty military patients can be a challenge, but a significant number of trials are now recruiting patients from those patient populations. Many trials explicitly recruit patients from the VA, the military, and IHS. The VA Office of Research and Development alone sponsors or cosponsors nearly 1,000 research initiatives, and many more are sponsored by Walter Reed National Medical Center and other major defense and VA facilities. The clinical trials listed below are all open as of August 1, 201 8 ; have at least 1 VA, DoD, or IHS location recruiting patients; and are focused on treatment for colorectal cancer. For additional information and full inclusion/exclusion criteria, please consult clinicaltrials.gov.

Lung-MAP (multiple trials)

Lung-MAP (SWOG S1400) is a multidrug, multi-substudy, biomarker-driven squamous cell lung cancer clinical trial that uses state-of-the-art genomic profiling to match patients to substudies testing investigational treatments that may target the genomic alterations, or mutations, found to be driving the growth of their cancer.

ID: NCT02154490, NCT02595944, NCT02766335, NCT02785913, NCT02785939, NCT02926638, NCT02965378, NCT03373760, NCT03377556
Sponsor: Southwest Oncology Group
Locations: VA Connecticut Healthcare System-West Haven Campus; Hines VA Hospital, Illinois; Richard L. Roudebush VAMC, Indianapolis, Indiana; Ann Arbor VAMC, Michigan; Kansas City VAMC, Missouri; VA New Jersey Health Care System, East Orange; Michael E. DeBakey VAMC Houston, Texas

ALCHEMIST: Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trials (multiple trials)

A group of randomized clinical trials for patients with early-stage non-small cell lung cancer whose tumors have been completely removed by surgery.

ID: NCT02193282, NCT02194738, NCT02201992, NCT02595944
Sponsor: National Cancer Institute
Locations: Little Rock VAMC, Arkansas; VA Connecticut Healthcare System West Haven Campus; Atlanta VAMC, Decatur, Georgia; Hines VA Hospital, Illinois; Richard L. Roudebush VAMC, Indianapolis, Indiana; Minneapolis VAMC, Minnesota; Saint Louis VAMC, Missouri; Veterans Affairs New York Harbor Healthcare System-Brooklyn Campus; Dayton VAMC, Ohio; William S. Middleton VAMC, Madison, Wisconsin

Veterans Affairs Lung Cancer Or Stereotactic Radiotherapy (VALOR)

The standard of care for stage I non-small cell lung cancer has historically been surgical resection in patients who are medically fit to tolerate an operation. Recent data now suggests that stereotactic radiotherapy may be a suitable alternative. This includes the results from a pooled analysis of two incomplete phase III studies that reported a 15% overall survival advantage with stereotactic radiotherapy at 3 years. While these data are promising, the median follow-up period was short, the results underpowered, and the findings were in contradiction to multiple retrospective studies that demonstrate the outcomes with surgery are likely equal or superior. Therefore, the herein trial aims to evaluate these two treatments in a prospective randomized fashion with a goal to compare the overall survival beyond 5 years. It has been designed to enroll patients who have a long life-expectancy, and are fit enough to tolerate an anatomic pulmonary resection with intraoperative lymph node sampling.

ID: NCT02984761
Sponsor: VA Office of Research and Development
Locations: Edward Hines Jr. VA Hospital, Hines, Illinois; Richard L. Roudebush VA Medical Center, Indianapolis, Indiana; Minneapolis VA Health Care System, Minnesota; Durham VAMC, North Carolina; Michael E. DeBakey VAMC, Houston, Texas; Hunter Holmes McGuire VA Medical Center, Richmond, Virginia

Naloxegol in Treating Patients With Stage IIIB-IV Non-Small Cell Lung Cancer

This randomized pilot clinical trial studies the side effects and best dose of naloxegol and to see how well it works in treating patients with stage IIIB-IV non-small cell lung cancer. Naloxegol may relieve some of the side effects of opioid pain medication and fight off future growth in the cancer.

ID: NCT03087708
Sponsor: Alliance for Clinical Trials in Oncology
Locations: Minneapolis VAMC, Minnesota; Kansas City VAMC, Missouri; VA Western New York Health Care System-Buffalo; Salisbury VAMC, North Carolina

Palliative Care Interventions for Outpatients Newly Diagnosed With Lung Cancer: Phase II (PCI2)

The focus of the study is to test a nurse-led telephone-based palliative care intervention on improving the delivery of care for patients with newly diagnosed lung cancer. The study is a three site randomized control trial to determine the efficacy of the intervention on improving patients’ quality of life, symptom burden, and satisfaction of care. Additionally, the study will test an innovative care delivery model to improve patients’ access to palliative care. The investigators will also determine the effect of the intervention on patient activation to discuss treatment preferences with their clinician and on clinician knowledge of patients’ goals of care.

ID: NCT03007953
Sponsor: VA Office of Research and Development
Locations: Birmingham VAMC, Alabama; VA Portland Health Care System, Oregon; VA Puget Sound Health Care System Seattle Division, Washington

Radiation Therapy Regimens in Treating Patients With Limited-Stage Small Cell Lung Cancer Receiving Cisplatin and Etoposide

Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as etoposide, carboplatin and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known which radiation therapy regimen is more effective when given together with chemotherapy in treating patients with limited-stage small cell lung cancer. This randomized phase III trial is comparing different chest radiation therapy regimens to see how well they work in treating patients with limited-stage small cell lung cancer.

ID: NCT00632853
Sponsor: Alliance for Clinical Trials in Oncology
Locations: Baltimore VAMC, Maryland; Kansas City VAMC, Missouri; VA Western New York Health Care System, Buffalo, New York; Dayton VAMC, Ohio; Zablocki VAMC, Milwaukee, Wisconsin

Comparison of Different Types of Surgery in Treating Patients With Stage IA Non-Small Cell Lung Cancer

Wedge resection or segmentectomy may be less invasive types of surgery than lobectomy for non-small cell lung cancer and may have fewer side effects and improve recovery. It is not yet known whether wedge resection or segmentectomy are more effective than lobectomy in treating stage IA non-small cell lung cancer.

ID: NCT00499330
Sponsor: Alliance for Clinical Trials in Oncology
Locations: VA Loma Linda Healthcare System, California; VA Long Beach Medical Center, California; Richard L. Roudebush VAMC, Indianapolis, Indiana; Portland VAMC, Oregon

Lung Cancer Screening Decisions (VA-LCSDecTool)

Veterans have a high risk of developing lung in comparison to general populations due to their older age and smoking history. Recent evidence indicates that lung cancer screening with low dose CT scan reduces lung cancer mortality among older heavy smokers. However, the rates of false positive findings are high, requiring further testing and evaluation. Preliminary studies report that while some Veterans are enthusiastic about screening, others are highly reluctant. Patient preferences should be considered as part of an informed decision making process for this emerging paradigm of lung cancer control. Effective methods for preference assessment among Veterans have not yet been developed, evaluated, and integrated into clinical practice. The specific aims of this study are to 1) elicit patient and provider stakeholder input to inform the development of a lung cancer screening decision tool, 2) develop a web based Lung Cancer Screening Decision Tool (LCSDecTool) that incorporates patient and provider input, and 3) evaluate the impact of the LCSDecTool compared to usual care on the decision process, clinical outcomes, and quality of life.

ID: NCT02899754
Sponsor: VA Office of Research and Development
Locations: VA Connecticut Healthcare System West Haven Campus; Corporal Michael J. Crescenz VAMC Philadelphia, Pennsylvania

Molecular Predictors of Cancer in Patients at High Risk of Lung Cancer

Using samples of blood, urine, sputum, and lung tissue from patients at high risk of cancer for laboratory studies may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.

ID: NCT00898313
Sponsor: Vanderbilt-Ingram Cancer Center
Location: VAMC Nashville, Tennessee

Improving Supportive Care for Patients With Thoracic Malignancies

The purpose of this study is to use a proactive approach to improve symptom management of patients with thoracic malignancies. In this pilot study, the investigators propose to evaluate the feasibility of using outbound, proactive telephone symptom assessment strategies and measure the efficacy of this approach on patient satisfaction with their care, patient activation, quality of life and use of healthcare resources.

ID: NCT03216109
Sponsor: Palo Alto Veterans Institute for Research
Location: VA Palo Alto Health Care System, California

Providing access to clinical trials for veteran and active-duty military patients can be a challenge, but a significant number of trials are now recruiting patients from those patient populations. Many trials explicitly recruit patients from the VA, the military, and IHS. The VA Office of Research and Development alone sponsors or cosponsors nearly 1,000 research initiatives, and many more are sponsored by Walter Reed National Medical Center and other major defense and VA facilities. The clinical trials listed below are all open as of August 1, 201 8 ; have at least 1 VA, DoD, or IHS location recruiting patients; and are focused on treatment for colorectal cancer. For additional information and full inclusion/exclusion criteria, please consult clinicaltrials.gov.

Lung-MAP (multiple trials)

Lung-MAP (SWOG S1400) is a multidrug, multi-substudy, biomarker-driven squamous cell lung cancer clinical trial that uses state-of-the-art genomic profiling to match patients to substudies testing investigational treatments that may target the genomic alterations, or mutations, found to be driving the growth of their cancer.

ID: NCT02154490, NCT02595944, NCT02766335, NCT02785913, NCT02785939, NCT02926638, NCT02965378, NCT03373760, NCT03377556
Sponsor: Southwest Oncology Group
Locations: VA Connecticut Healthcare System-West Haven Campus; Hines VA Hospital, Illinois; Richard L. Roudebush VAMC, Indianapolis, Indiana; Ann Arbor VAMC, Michigan; Kansas City VAMC, Missouri; VA New Jersey Health Care System, East Orange; Michael E. DeBakey VAMC Houston, Texas

ALCHEMIST: Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trials (multiple trials)

A group of randomized clinical trials for patients with early-stage non-small cell lung cancer whose tumors have been completely removed by surgery.

ID: NCT02193282, NCT02194738, NCT02201992, NCT02595944
Sponsor: National Cancer Institute
Locations: Little Rock VAMC, Arkansas; VA Connecticut Healthcare System West Haven Campus; Atlanta VAMC, Decatur, Georgia; Hines VA Hospital, Illinois; Richard L. Roudebush VAMC, Indianapolis, Indiana; Minneapolis VAMC, Minnesota; Saint Louis VAMC, Missouri; Veterans Affairs New York Harbor Healthcare System-Brooklyn Campus; Dayton VAMC, Ohio; William S. Middleton VAMC, Madison, Wisconsin

Veterans Affairs Lung Cancer Or Stereotactic Radiotherapy (VALOR)

The standard of care for stage I non-small cell lung cancer has historically been surgical resection in patients who are medically fit to tolerate an operation. Recent data now suggests that stereotactic radiotherapy may be a suitable alternative. This includes the results from a pooled analysis of two incomplete phase III studies that reported a 15% overall survival advantage with stereotactic radiotherapy at 3 years. While these data are promising, the median follow-up period was short, the results underpowered, and the findings were in contradiction to multiple retrospective studies that demonstrate the outcomes with surgery are likely equal or superior. Therefore, the herein trial aims to evaluate these two treatments in a prospective randomized fashion with a goal to compare the overall survival beyond 5 years. It has been designed to enroll patients who have a long life-expectancy, and are fit enough to tolerate an anatomic pulmonary resection with intraoperative lymph node sampling.

ID: NCT02984761
Sponsor: VA Office of Research and Development
Locations: Edward Hines Jr. VA Hospital, Hines, Illinois; Richard L. Roudebush VA Medical Center, Indianapolis, Indiana; Minneapolis VA Health Care System, Minnesota; Durham VAMC, North Carolina; Michael E. DeBakey VAMC, Houston, Texas; Hunter Holmes McGuire VA Medical Center, Richmond, Virginia

Naloxegol in Treating Patients With Stage IIIB-IV Non-Small Cell Lung Cancer

This randomized pilot clinical trial studies the side effects and best dose of naloxegol and to see how well it works in treating patients with stage IIIB-IV non-small cell lung cancer. Naloxegol may relieve some of the side effects of opioid pain medication and fight off future growth in the cancer.

ID: NCT03087708
Sponsor: Alliance for Clinical Trials in Oncology
Locations: Minneapolis VAMC, Minnesota; Kansas City VAMC, Missouri; VA Western New York Health Care System-Buffalo; Salisbury VAMC, North Carolina

Palliative Care Interventions for Outpatients Newly Diagnosed With Lung Cancer: Phase II (PCI2)

The focus of the study is to test a nurse-led telephone-based palliative care intervention on improving the delivery of care for patients with newly diagnosed lung cancer. The study is a three site randomized control trial to determine the efficacy of the intervention on improving patients’ quality of life, symptom burden, and satisfaction of care. Additionally, the study will test an innovative care delivery model to improve patients’ access to palliative care. The investigators will also determine the effect of the intervention on patient activation to discuss treatment preferences with their clinician and on clinician knowledge of patients’ goals of care.

ID: NCT03007953
Sponsor: VA Office of Research and Development
Locations: Birmingham VAMC, Alabama; VA Portland Health Care System, Oregon; VA Puget Sound Health Care System Seattle Division, Washington

Radiation Therapy Regimens in Treating Patients With Limited-Stage Small Cell Lung Cancer Receiving Cisplatin and Etoposide

Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as etoposide, carboplatin and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known which radiation therapy regimen is more effective when given together with chemotherapy in treating patients with limited-stage small cell lung cancer. This randomized phase III trial is comparing different chest radiation therapy regimens to see how well they work in treating patients with limited-stage small cell lung cancer.

ID: NCT00632853
Sponsor: Alliance for Clinical Trials in Oncology
Locations: Baltimore VAMC, Maryland; Kansas City VAMC, Missouri; VA Western New York Health Care System, Buffalo, New York; Dayton VAMC, Ohio; Zablocki VAMC, Milwaukee, Wisconsin

Comparison of Different Types of Surgery in Treating Patients With Stage IA Non-Small Cell Lung Cancer

Wedge resection or segmentectomy may be less invasive types of surgery than lobectomy for non-small cell lung cancer and may have fewer side effects and improve recovery. It is not yet known whether wedge resection or segmentectomy are more effective than lobectomy in treating stage IA non-small cell lung cancer.

ID: NCT00499330
Sponsor: Alliance for Clinical Trials in Oncology
Locations: VA Loma Linda Healthcare System, California; VA Long Beach Medical Center, California; Richard L. Roudebush VAMC, Indianapolis, Indiana; Portland VAMC, Oregon

Lung Cancer Screening Decisions (VA-LCSDecTool)

Veterans have a high risk of developing lung in comparison to general populations due to their older age and smoking history. Recent evidence indicates that lung cancer screening with low dose CT scan reduces lung cancer mortality among older heavy smokers. However, the rates of false positive findings are high, requiring further testing and evaluation. Preliminary studies report that while some Veterans are enthusiastic about screening, others are highly reluctant. Patient preferences should be considered as part of an informed decision making process for this emerging paradigm of lung cancer control. Effective methods for preference assessment among Veterans have not yet been developed, evaluated, and integrated into clinical practice. The specific aims of this study are to 1) elicit patient and provider stakeholder input to inform the development of a lung cancer screening decision tool, 2) develop a web based Lung Cancer Screening Decision Tool (LCSDecTool) that incorporates patient and provider input, and 3) evaluate the impact of the LCSDecTool compared to usual care on the decision process, clinical outcomes, and quality of life.

ID: NCT02899754
Sponsor: VA Office of Research and Development
Locations: VA Connecticut Healthcare System West Haven Campus; Corporal Michael J. Crescenz VAMC Philadelphia, Pennsylvania

Molecular Predictors of Cancer in Patients at High Risk of Lung Cancer

Using samples of blood, urine, sputum, and lung tissue from patients at high risk of cancer for laboratory studies may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.

ID: NCT00898313
Sponsor: Vanderbilt-Ingram Cancer Center
Location: VAMC Nashville, Tennessee

Improving Supportive Care for Patients With Thoracic Malignancies

The purpose of this study is to use a proactive approach to improve symptom management of patients with thoracic malignancies. In this pilot study, the investigators propose to evaluate the feasibility of using outbound, proactive telephone symptom assessment strategies and measure the efficacy of this approach on patient satisfaction with their care, patient activation, quality of life and use of healthcare resources.

ID: NCT03216109
Sponsor: Palo Alto Veterans Institute for Research
Location: VA Palo Alto Health Care System, California

Administering an HIV drug concurrently with chemoradiotherapy resulted in promising local control and overall survival in patients with unresectable, locally advanced non–small cell lung cancer, researchers reported.

There was no overt exacerbation of the toxic effects of chemoradiotherapy with the addition of nelfinavir, a protease inhibitor, in the prospective, open-label, phase 1/2 study, the researchers wrote.

Nelfinavir plus chemoradiotherapy yielded a median progression-free survival of 11.7 months and median survival of 41.1 months, while the cumulative local failure incidence was 39% according to their report.

Those outcomes compare favorably with historical data, the investigators wrote in JAMA Oncology.

In benchmark results of the RTOG 0617 study of chemoradiotherapy in locally advanced non–small cell lung cancer, median overall survival was 28.7 months receiving radiotherapy at a standard dose of 60 Gy, and 20.3 months for those receiving high-dose (74 Gy) radiotherapy.

However, a randomized, phase 3 trial is needed to confirm these latest results with a protease inhibitor added to chemotherapy, according to Ramesh Rengan, MD, PhD, of the University of Washington, Seattle, and coinvestigators.

“As nelfinavir is a U.S. Food and Drug Administration–approved oral drug, this treatment approach is feasible and is potentially a readily exportable platform for daily clinical use,” Dr. Rengan and coauthors wrote.

In vitro and in vivo studies have shown that nelfinavir inhibited PI3K and Akt signaling, sensitized tumor cells to ionizing radiation, and improved tumor perfusion in animal models. “We hypothesize that it is these properties that drive the clinical results observed in this study,” Dr. Rengan and coauthors wrote.

They reported on a total of 35 patients with stage IIIA/IIIB non–small cell lung cancer who received nelfinavir at either 625 mg or 1,250 mg twice daily, starting 7-14 days before starting radiotherapy to 66.6 Gy at 1.8 Gy per fraction, and throughout the full course of radiotherapy.

There were no dose-limiting toxic effects observed in the study, and toxic effects were “acceptable,” with no grade 4 nonhematologic toxic effects seen, according to investigators. Leukopenia was the primary grade 3-4 hematologic toxic effect, observed in 2 of 5 patients receiving the lower nelfinavir dose and 18 of 30 at the higher dose.

Beyond non–small cell lung cancer, the efficacy and safety nelfinavir given concurrently with radiotherapy has been looked at in other disease settings. Data from those trials suggest that this protease inhibitor could “augment tumor response” not only in non–small cell lung cancer, but in locally advanced pancreatic cancer and glioblastoma, all of which are relatively radioresistant, according to Dr. Rengan and colleagues.

Study support came from grants from the National Institutes of Health and Abramson Cancer Center, and an American Society for Radiation Oncology training award to Dr. Rengan. Study authors reported disclosures related to Pfizer, 511 Pharma, Progenics Pharmaceuticals, Siemens, Actinium, AstraZeneca, Merck, Bristol-Myers Squibb, and others.

SOURCE: Rengan R et al. JAMA Oncol. 2019 Aug 22. doi: 10.1001/jamaoncol.2019.2095.

Administering an HIV drug concurrently with chemoradiotherapy resulted in promising local control and overall survival in patients with unresectable, locally advanced non–small cell lung cancer, researchers reported.

There was no overt exacerbation of the toxic effects of chemoradiotherapy with the addition of nelfinavir, a protease inhibitor, in the prospective, open-label, phase 1/2 study, the researchers wrote.

Nelfinavir plus chemoradiotherapy yielded a median progression-free survival of 11.7 months and median survival of 41.1 months, while the cumulative local failure incidence was 39% according to their report.

Those outcomes compare favorably with historical data, the investigators wrote in JAMA Oncology.

In benchmark results of the RTOG 0617 study of chemoradiotherapy in locally advanced non–small cell lung cancer, median overall survival was 28.7 months receiving radiotherapy at a standard dose of 60 Gy, and 20.3 months for those receiving high-dose (74 Gy) radiotherapy.

However, a randomized, phase 3 trial is needed to confirm these latest results with a protease inhibitor added to chemotherapy, according to Ramesh Rengan, MD, PhD, of the University of Washington, Seattle, and coinvestigators.

“As nelfinavir is a U.S. Food and Drug Administration–approved oral drug, this treatment approach is feasible and is potentially a readily exportable platform for daily clinical use,” Dr. Rengan and coauthors wrote.

In vitro and in vivo studies have shown that nelfinavir inhibited PI3K and Akt signaling, sensitized tumor cells to ionizing radiation, and improved tumor perfusion in animal models. “We hypothesize that it is these properties that drive the clinical results observed in this study,” Dr. Rengan and coauthors wrote.

They reported on a total of 35 patients with stage IIIA/IIIB non–small cell lung cancer who received nelfinavir at either 625 mg or 1,250 mg twice daily, starting 7-14 days before starting radiotherapy to 66.6 Gy at 1.8 Gy per fraction, and throughout the full course of radiotherapy.

There were no dose-limiting toxic effects observed in the study, and toxic effects were “acceptable,” with no grade 4 nonhematologic toxic effects seen, according to investigators. Leukopenia was the primary grade 3-4 hematologic toxic effect, observed in 2 of 5 patients receiving the lower nelfinavir dose and 18 of 30 at the higher dose.

Beyond non–small cell lung cancer, the efficacy and safety nelfinavir given concurrently with radiotherapy has been looked at in other disease settings. Data from those trials suggest that this protease inhibitor could “augment tumor response” not only in non–small cell lung cancer, but in locally advanced pancreatic cancer and glioblastoma, all of which are relatively radioresistant, according to Dr. Rengan and colleagues.

Study support came from grants from the National Institutes of Health and Abramson Cancer Center, and an American Society for Radiation Oncology training award to Dr. Rengan. Study authors reported disclosures related to Pfizer, 511 Pharma, Progenics Pharmaceuticals, Siemens, Actinium, AstraZeneca, Merck, Bristol-Myers Squibb, and others.

SOURCE: Rengan R et al. JAMA Oncol. 2019 Aug 22. doi: 10.1001/jamaoncol.2019.2095.

Administering an HIV drug concurrently with chemoradiotherapy resulted in promising local control and overall survival in patients with unresectable, locally advanced non–small cell lung cancer, researchers reported.

There was no overt exacerbation of the toxic effects of chemoradiotherapy with the addition of nelfinavir, a protease inhibitor, in the prospective, open-label, phase 1/2 study, the researchers wrote.

Nelfinavir plus chemoradiotherapy yielded a median progression-free survival of 11.7 months and median survival of 41.1 months, while the cumulative local failure incidence was 39% according to their report.

Those outcomes compare favorably with historical data, the investigators wrote in JAMA Oncology.

In benchmark results of the RTOG 0617 study of chemoradiotherapy in locally advanced non–small cell lung cancer, median overall survival was 28.7 months receiving radiotherapy at a standard dose of 60 Gy, and 20.3 months for those receiving high-dose (74 Gy) radiotherapy.

However, a randomized, phase 3 trial is needed to confirm these latest results with a protease inhibitor added to chemotherapy, according to Ramesh Rengan, MD, PhD, of the University of Washington, Seattle, and coinvestigators.

“As nelfinavir is a U.S. Food and Drug Administration–approved oral drug, this treatment approach is feasible and is potentially a readily exportable platform for daily clinical use,” Dr. Rengan and coauthors wrote.

In vitro and in vivo studies have shown that nelfinavir inhibited PI3K and Akt signaling, sensitized tumor cells to ionizing radiation, and improved tumor perfusion in animal models. “We hypothesize that it is these properties that drive the clinical results observed in this study,” Dr. Rengan and coauthors wrote.

They reported on a total of 35 patients with stage IIIA/IIIB non–small cell lung cancer who received nelfinavir at either 625 mg or 1,250 mg twice daily, starting 7-14 days before starting radiotherapy to 66.6 Gy at 1.8 Gy per fraction, and throughout the full course of radiotherapy.

There were no dose-limiting toxic effects observed in the study, and toxic effects were “acceptable,” with no grade 4 nonhematologic toxic effects seen, according to investigators. Leukopenia was the primary grade 3-4 hematologic toxic effect, observed in 2 of 5 patients receiving the lower nelfinavir dose and 18 of 30 at the higher dose.

Beyond non–small cell lung cancer, the efficacy and safety nelfinavir given concurrently with radiotherapy has been looked at in other disease settings. Data from those trials suggest that this protease inhibitor could “augment tumor response” not only in non–small cell lung cancer, but in locally advanced pancreatic cancer and glioblastoma, all of which are relatively radioresistant, according to Dr. Rengan and colleagues.

Study support came from grants from the National Institutes of Health and Abramson Cancer Center, and an American Society for Radiation Oncology training award to Dr. Rengan. Study authors reported disclosures related to Pfizer, 511 Pharma, Progenics Pharmaceuticals, Siemens, Actinium, AstraZeneca, Merck, Bristol-Myers Squibb, and others.

SOURCE: Rengan R et al. JAMA Oncol. 2019 Aug 22. doi: 10.1001/jamaoncol.2019.2095.