Veterans Affairs Lung Cancer Surgery Or Stereotactic Radiotherapy (VALOR)
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|ClinicalTrials.gov Identifier: NCT02984761|
Recruitment Status : Recruiting
First Posted : December 7, 2016
Last Update Posted : September 24, 2020
|Condition or disease||Intervention/treatment||Phase|
|Lung Neoplasm||Radiation: Stereotactic Radiotherapy Procedure: Anatomic Pulmonary Resection||Not Applicable|
**As a consequence of the COVID-19 pandemic, and after consultation with the appropriate research oversight, regulatory and monitoring entities, screening and enrollment has been placed on temporary administrative hold as of 03/17/2020. When such trial activities resume the clinicaltrials.gov record will be updated accordingly. As of 9/16/2020 Minneapolis, Richmond, and Houston are still on Administrative Hold for the CSP 2005 study. The other 6 sites are open for recruitment. **
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.
This study is designed to open at Veterans Affairs medical centers with expertise in both treatments. The recruitment process includes shared decision making and multi-disciplinary evaluations with lung cancer specialists. Mandatory evaluations before randomization include tissue confirmation of NSCLC, staging with FDG-PET/CT, and biopsies of all hilar and/or mediastinal lymph nodes >10mm that have a SUV >2.5. Pre-randomization elective lymph node sampling is strongly encouraged, but not required. Following treatment, patients will be followed for a minimum of 5 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||670 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||CSP #2005 - Veterans Affairs Lung Cancer Surgery Or Stereotactic Radiotherapy Trial (VALOR)|
|Actual Study Start Date :||April 13, 2017|
|Estimated Primary Completion Date :||September 30, 2026|
|Estimated Study Completion Date :||September 30, 2027|
Experimental: Stereotactic radiotherapy
Stereotactic radiotherapy is an FDA approved treatment for lung cancer. However, for purposes of this study, it is being delivered to an operable population that is typically treated with surgical resection. Participants randomized to stereotactic radiotherapy will be treated according to the location of the tumor. Peripheral tumors will receive either 18 Gy x 3, 14 Gy x 4, or 11.5 Gy x 5 fractions, while central tumors will be treated with 10 Gy x 5. There will not be any elective coverage of local microscopic spread or regional lymph nodes.
Radiation: Stereotactic Radiotherapy
Stereotactic radiotherapy uses high doses of ionizing energy to treat cancer cells with image guidance. The treatment is delivered in an outpatient setting, and for purposes of this trial is delivered in 3-5 fractions.
Other Name: Stereotactic Body Radiation Therapy (SBRT) or Stereotactic Ablative Radiotherapy (SAbR)
Active Comparator: Surgery
Participants randomized to surgery will undergo a standard lobectomy or limited anatomic pulmonary resection (segmentectomy) under general anesthesia. Non-anatomic (wedge) resections are not permitted. Pathological specimens must contain a separately divided pulmonary artery and bronchus, as well as sampled lymph nodes from mediastinal lymph node stations. Participants found to have incidental nodal involvement after surgery will be referred for adjuvant chemotherapy, with our without postoperative radiotherapy.
Procedure: Anatomic Pulmonary Resection
An anatomic pulmonary resection is an oncologic procedure that dissects out an anatomically defined segment of the lung to remove all of the lung tissue around a lung tumor. It requires an operation with general anesthesia, with a short hospital stay. The procedure entails removal of lymph nodes inside the chest that might not be easily accessible without an operation.
Other Name: Lobectomy or Anatomic Segmentectomy
- Overall Survival [ Time Frame: From date of randomization through study completion, up to 10 years ]Survival estimates will include death from any cause.
- Patient reported health-related quality of life [ Time Frame: 5 years ]The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and Lung Cancer (LC 13) survey instruments will assess patients' general state of physical, social/family, emotional and functional well-being.
- Respiratory Symptoms [ Time Frame: 5 years ]The St George's Respiratory Questionnaire will evaluate respiratory symptoms, activity limitations from breathlessness, and impact of respiratory function on social and psychological functioning.
- Health State Utilities [ Time Frame: 5 years ]The EQ-5D-5L (EuroQOL-5D) survey will measure quality adjusted life years.
- Lung cancer mortality [ Time Frame: From date of randomization until date of death from any cause, assessed up to 10 years. ]Cause of death will be determined by an independent adjudication committee.
- Tumor patterns of failure [ Time Frame: 5 years ]Post-treatment surveillance imaging will evaluate patients every 6 months for local, regional, and/or distant disease control.
- Respiratory Function [ Time Frame: 5 years ]The Forced Expiratory Volume at 1 second (FEV1) will evaluate an objective measure of breathing function.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02984761
|Contact: Drew Moghanaki, MD MPH||(804) 306-9045||Drew.Moghanaki@va.gov|
|Contact: Vicki L Skinner, RN||(894) firstname.lastname@example.org|
|United States, California|
|VA Long Beach Healthcare System, Long Beach, CA||Recruiting|
|Long Beach, California, United States, 90822|
|Contact: Bahman Saatian, MD 562-826-5591 email@example.com|
|Contact: Gelincik K Orakcilar, MS 5628268000 ext 24172 firstname.lastname@example.org|
|United States, Florida|
|Bay Pines VA Healthcare System, Pay Pines, FL||Recruiting|
|Bay Pines, Florida, United States, 33744|
|Contact: Edward Hong, MD 727-398-6661 ext 6661 email@example.com|
|Contact: Ryan J Burri, MD 7273986661 ext 13912 firstname.lastname@example.org|
|United States, Georgia|
|Atlanta VA Medical and Rehab Center, Decatur, GA||Active, not recruiting|
|Decatur, Georgia, United States, 30033|
|United States, Illinois|
|Edward Hines Jr. VA Hospital, Hines, IL||Recruiting|
|Hines, Illinois, United States, 60141-5000|
|Contact: Cheryl Czerlanis, MD Cheryl.Czerlanis@va.gov|
|Contact: Eliza Kintanar, RN Eliza.email@example.com|
|United States, Indiana|
|Richard L. Roudebush VA Medical Center, Indianapolis, IN||Recruiting|
|Indianapolis, Indiana, United States, 46202-2884|
|Contact: Catherine Sears, MD Catherine.Sears@va.gov|
|Contact: Sharon Weitlauf, RN Sharon.Weitlauf@va.gov|
|United States, Minnesota|
|Minneapolis VA Health Care System, Minneapolis, MN||Recruiting|
|Minneapolis, Minnesota, United States, 55417|
|Contact: Erin Wetherbee, MD Erin.Wetherbee.@va.gov|
|Contact: Aimee Hamel 6124675806 Aimee.Hamel@va.gov|
|United States, North Carolina|
|Durham VA Medical Center, Durham, NC||Recruiting|
|Durham, North Carolina, United States, 27705|
|Contact: Scott Shofer, MD Scott.Shofer@va.gov|
|Contact: Melissa A Wagner, BS 9192860411 ext 7599 firstname.lastname@example.org|
|United States, Pennsylvania|
|VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15240|
|Contact: Charles W Atwood, MD 412-360-6316 email@example.com|
|Contact: Gregory A Owens, BA 4123601517 firstname.lastname@example.org|
|United States, Texas|
|Michael E. DeBakey VA Medical Center, Houston, TX||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Lorraine Cornwell, MD Lorraine.Cornwell@va.gov|
|Contact: Adriana M Rueda, MS 7137947459|
|United States, Virginia|
|Hunter Holmes McGuire VA Medical Center, Richmond, VA||Recruiting|
|Richmond, Virginia, United States, 23249|
|Contact: Leonard C Moses, MD 804-675-5606 Leonard.Moses@va.gov|
|Contact: Pamela Parker, RN 8046755000 ext 6136 Pamela.Parker8@va.gov|
|Study Chair:||Drew Moghanaki, MD MPH||Atlanta VA Medical and Rehab Center, Decatur, GA|
|Study Chair:||David H Harpole, MD||Durham VA Medical Center, Durham, NC|