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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.

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.

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.

Stereotactic Radiotherapy

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.

Anatomic Pulmonary Resection

Cheryl C Odle, MBA

Matt Leiner, MS

Bahman Saatian, MD

Gelincik K Orakcilar, MS

Drew Moghanaki, MD MPH

Vicki L Skinner, RN

Diane L Gage, MD

Robert B Cameron, MD

Edward Hong, MD

Ryan J Burri, MD

Gregory Holt, MD

Jalima Quintero

Cheryl Czerlanis, MD

Eliza Kintanar, RN

Catherine Sears, MD

Sharon Henson, RN

Janaki Deepak, MD

Ma Inez A Ambata, MSN

Ronald Goldstein, MD

Kathleen Lacerda

Jane Deng, MD

David Elliott, MD

Erin Wetherbee, MD

Taira Miller

Scott Shofer, MD

Melissa A Wagner, BS

Charles Nock, MD

Lisa Tucker

Anil Vachani, MD

Jennifer Steltz

Charles W Atwood, MD

Gregory A Owens, BA

Lorraine Cornwell, MD

Adriana M Rueda, MS

Andreea Anton, MD

Kayla Neuendorf, BSN

David H Harpole, MD

Patients with stage I non-small cell lung cancer have been historically treated with surgery whenever they are fit for an operation. However, an alternative treatment known as stereotactic radiotherapy now appears to offer an equally effective alternative. Doctors believe both are good treatments and are therefore conducting this study to determine if one may be possibly better than the other.

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.

Veterans Affairs Lung Cancer Surgery Or Stereotactic Radiotherapy

CSP #2005 - Veterans Affairs Lung Cancer Surgery Or Stereotactic Radiotherapy Trial (VALOR)

Survival estimates will include death from any cause.

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.

The St George's Respiratory Questionnaire will evaluate respiratory symptoms, activity limitations from breathlessness, and impact of respiratory function on social and psychological functioning.

The EQ-5D-5L (EuroQOL-5D) survey will measure quality adjusted life years.

Cause of death will be determined by an independent adjudication committee.

Post-treatment surveillance imaging will evaluate patients every 6 months for local, regional, and/or distant disease control.

The Forced Expiratory Volume at 1 second (FEV1) will evaluate an objective measure of breathing function.

VA Office of Research and Development

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Veterans Affairs Lung Cancer Surgery Or Stereotactic Radiotherapy	NCT02984761	Lung Neoplasm	Stereotactic Ra... Anatomic Pulmon...	18 Years -	VA Office of Research and Development
Veterans Affairs Lung Cancer Surgery Or Stereotactic Radiotherapy	NCT02984761	Lung Neoplasm	Stereotactic Ra... Anatomic Pulmon...	18 Years -	VA Office of Research and Development

Spots Global Cancer Trial Database for anatomic pulmonary resection