Recruiting

Stereotactic Radiotherapy vs. SurgeryVeterans Affairs Lung Cancer Surgery Or Stereotactic Radiotherapy

Sponsor:

VA Office of Research and Development

Code:

NCT02984761

Conditions

Lung Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Stereotactic Radiotherapy

Anatomic Pulmonary Resection

Study Details

Brief summary:

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.

Conditions

Lung Neoplasm

Study ID

NCT02984761

Start date

Apr 13, 2017

Status verified date

Feb, 2026

Completion date

Mar 31, 2034

Anticipated

Primary completion date

Sep 30, 2032

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Inclusion Criteria for Screening

Age 18 or older
Any patient with a preliminary diagnosis of stage I Non-Small Cell Lung Cancer (NSCLC), whether pathologically proven by biopsy, or highly suspicious by radiographic imaging. \[Participants will ultimately need biopsy confirmation before enrolling\]
Primary tumor size less than or equal to 5 cm by CT (may include CT images from PET/CT)
Karnofsky performance status greater than or equal to 70
Participant has willingness and ability to provided informed consent for participation

Inclusion Criteria for Randomization

Biopsy proven non-small cell lung cancer
Participant's case reviewed at multidisciplinary conference
Tumor size less than or equal to 5cm (measured on the most recent CT images available, and may include PET/CT images)
Tumor is equal to or greater than 1.0cm from the trachea, esophagus, brachial plexus, 1st bifurcation of the proximal bronchial tree, or spinal cord (measured on the most recent CT images available, and may include PET/CT images).
Mandatory FDG-PET/CT within 60 days of the randomization date (note: FDG-PET/CT may need to be repeated prior to treatment if outside of this requirement)
Mandatory pathological assessment of any lymph nodes >10mm with a SUV >2.5 seen on FDG- PET/CT
Mandatory biopsy of any additional concerning lesions seen on FDG-PET/CT, to make better determination that the patient is not harboring metastatic disease or a secondary primary malignancy.
Pre-operative FEV1 greater than or equal to 40% of predicted value and pre-operative DLCO greater than or equal to 40% of predicted value.
Formally evaluated and documented by a local thoracic surgeon to be medically fit to undergo a complete anatomic pulmonary resection (wedge resection not allowed)
Formally evaluated and documented by a local radiation oncologist to be eligible to receive protocol-defined stereotactic radiotherapy
Participant willingness to be randomized

Exclusion Criteria:

Exclusion Criteria for Screening

Previously evaluated by a local thoracic surgeon and determined to be medically inoperable
Pathological confirmation of nodal or distant metastasis
Prior history of lung cancer, not including current lesion
Prior history of thoracic surgery or lung or esophageal cancer. \[prior cardiac surgery acceptable\]
Prior history of radiotherapy to the thorax
Prior history of invasive state I-III malignancy treated with surgery, radiation therapy, chemotherapy, immunotherapy, or targeted therapy in the past 2 years, excluding prostate cancer, low-risk papillary thyroid cancer (less than or equal to 1 cm), follicular lymphoma, or chronic lymphocytic leukemia.
Prior history of IV malignancy, excluding follicular lymphoma, chronic lymphocytic leukemia, or hormone sensitive prostate cancer confined to the pelvis.
Ever diagnosed with stage IV metastatic cancer of any type
History of scleroderma
Positive Pregnancy test (for women <61 years of age or without prior hysterectomy)

Exclusion Criteria for Randomization

Pathological confirmation of nodal or metastatic disease

Study Design

Enrollment

670 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

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.

Primary outcome measure

Overall Survival [ Time Frame: From date of randomization through study completion, up to 10 years ]

Central Contacts and Locations

Central contacts

Drew Moghanaki, MD MPH

(804) 306-9045 Drew.Moghanaki@va.gov

Vicki L Skinner, RN

(894) 675-5105 vicki.skinner@va.gov

Locations

VA Long Beach Healthcare System, Long Beach, CA

Recruiting

Long Beach, California, United States, 90822

Contacts

Bahman Saatian, MD

562-826-5591 Bahman.Saatian@va.gov

Gelincik Orakcilar, MS

5628268000 Gelincik.Orakcilar@va.gov

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Recruiting

West Los Angeles, California, United States, 90073-1003

Contacts

Robert B Cameron, MD

310-794-7333 robert.cameron@va.gov

Diane L Gage, MD

(310) 478-3711 Diane.Gage@va.gov

Bay Pines VA Healthcare System, Pay Pines, FL

Recruiting

Bay Pines, Florida, United States, 33744-0000

Contacts

Edward Hong, MD

727-398-6661 Edward.Hong@va.gov

Ryan J Burri, MD

7273986661 Ryan.Burri@va.gov

Miami VA Healthcare System, Miami, FL

Recruiting

Miami, Florida, United States, 33125

Contacts

Gregory Holt, MD

305-575-7000 Gregory.Holt@va.gov

Jalima Quintero

3059928621 Jalima.Quintero@va.gov

Edward Hines Jr. VA Hospital, Hines, IL

Recruiting

Hines, Illinois, United States, 60141-3030

Contacts

Zaid M Abdelsattar, MD

Zaid.Abdelsattar@va.gov

Eliza Kintanar, RN

Eliza.Kintanar@va.gov

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Recruiting

Indianapolis, Indiana, United States, 46202-2884

Contacts

Catherine Sears, MD

Catherine.Sears@va.gov

Sharon Henson, RN

Sharon.Henson@va.gov

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Janaki Deepak, MD

410-605-7000 Janaki.Deepak@va.gov

Ma Inez A Ambata, MSN

MaInezAmparo.Ambata@va.gov

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Recruiting

Boston, Massachusetts, United States, 02130-4817

Contacts

Ronald Goldstein, MD

857-203-6478 Ronald.Goldstein@va.gov

Kathleen Lacerda

8572036295 Kathleen.Lacerda@va.gov

VA Ann Arbor Healthcare System, Ann Arbor, MI

Recruiting

Ann Arbor, Michigan, United States, 48105-2303

Contacts

Jane Deng, MD

734-845-3039 Jane.Deng@va.gov

David Elliott, MD

7348453914 David.Elliott1@va.gov

Minneapolis VA Health Care System, Minneapolis, MN

Recruiting

Minneapolis, Minnesota, United States, 55417-2309

Contacts

Erin Wetherbee, MD

Erin.Wetherbee.@va.gov

Taira Miller

Taira.Miller1@va.gov

Durham VA Medical Center, Durham, NC

Recruiting

Durham, North Carolina, United States, 27705-3875

Contacts

Scott Shofer, MD

Scott.Shofer@va.gov

Melissa A Wagner, BS

9192860411 Melissa.Wagner2@va.gov

Louis Stokes VA Medical Center, Cleveland, OH

Recruiting

Cleveland, Ohio, United States, 44106-1702

Contacts

Charles Nock, MD

216-791-3800 Charles.Nock@va.gov

Lisa Tucker

2167913800 Lisa.Tucker@va.gov

Michael E. DeBakey VA Medical Center, Houston, TX

Recruiting

Houston, Texas, United States, 77030-4211

Contacts

Lorraine Cornwell, MD

Lorraine.Cornwell@va.gov

Adriana M Rueda, MS

7137947459 Adriana.Rueda@va.gov

Clement J. Zablocki VA Medical Center, Milwaukee, WI

Recruiting

Milwaukee, Wisconsin, United States, 53295-0001

Contacts

Uzair Ghori, MD

414-384-2000 Uzair.Ghori@va.gov

Kayla Neuendorf, BSN

Kayla.Neuendorf@va.gov

More Information

Sponsor

VA Office of Research and Development

Last update posted

Feb 19, 2026

Last verified

Feb, 2026

Keywords

Carcinoma, Non-Small Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Radiosurgery
Radiotherapy
Radiotherapy, Image-Guided
Lung Neoplasms

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-02-19.