Veterans Affairs Lung Cancer Surgery Or Stereotactic Radiotherapy

NCT ID: NCT02984761

Last Updated: 2025-05-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 670 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-13
• Study Completion Date: 2027-09-30

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.

Detailed Description

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.

Conditions

Lung Neoplasm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Stereotactic Radiotherapy

Intervention Type: RADIATION

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.

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.

Group Type: ACTIVE_COMPARATOR

Anatomic Pulmonary Resection

Intervention Type: PROCEDURE

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.

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.

Intervention Type: RADIATION

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.

Intervention Type: PROCEDURE

Other Intervention Names

Stereotactic Body Radiation Therapy (SBRT) or Stereotactic Ablative Radiotherapy (SAbR); Lobectomy or Anatomic Segmentectomy

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• 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)

• Pathological confirmation of nodal or metastatic disease

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Drew Moghanaki, MD MPH

Role: STUDY_CHAIR

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

David H Harpole, MD

Role: STUDY_CHAIR

Durham VA Medical Center, Durham, NC

Locations

VA Long Beach Healthcare System, Long Beach, CA

Long Beach, California, United States

Site Status: RECRUITING

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

West Los Angeles, California, United States

Site Status: RECRUITING

Bay Pines VA Healthcare System, Pay Pines, FL

Bay Pines, Florida, United States

Site Status: RECRUITING

Miami VA Healthcare System, Miami, FL

Miami, Florida, United States

Site Status: RECRUITING

Edward Hines Jr. VA Hospital, Hines, IL

Hines, Illinois, United States

Site Status: RECRUITING

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Indianapolis, Indiana, United States

Site Status: RECRUITING

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

Baltimore, Maryland, United States

Site Status: RECRUITING

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

Boston, Massachusetts, United States

Site Status: RECRUITING

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, United States

Site Status: RECRUITING

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, United States

Site Status: RECRUITING

Durham VA Medical Center, Durham, NC

Durham, North Carolina, United States

Site Status: RECRUITING

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, United States

Site Status: RECRUITING

Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Philadelphia, Pennsylvania, United States

Site Status: TERMINATED

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, United States

Site Status: TERMINATED

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, United States

Site Status: RECRUITING

Hunter Holmes McGuire VA Medical Center, Richmond, VA

Richmond, Virginia, United States

Site Status: TERMINATED

Clement J. Zablocki VA Medical Center, Milwaukee, WI

Milwaukee, Wisconsin, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Drew Moghanaki, MD MPH

Role: CONTACT

Drew.Moghanaki@va.gov

(804) 306-9045

Matt Leiner, MS

Role: CONTACT

Matt.Leiner@va.gov

(708) 202-5853

Facility Contacts

Bahman Saatian, MD

Role: primary

Bahman.Saatian@va.gov

562-826-5591

Gelincik Orakcilar, MS

Role: backup

Gelincik.Orakcilar@va.gov

5628268000 ext. 24172

Robert B Cameron, MD

Role: primary

robert.cameron@va.gov

310-794-7333

Diane L Gage, MD

Role: backup

Diane.Gage@va.gov

(310) 478-3711

Edward Hong, MD

Role: primary

Edward.Hong@va.gov

727-398-6661 ext. 6661

Ryan J Burri, MD

Role: backup

Ryan.Burri@va.gov

7273986661 ext. 13912

Gregory Holt, MD

Role: primary

Gregory.Holt@va.gov

305-575-7000 ext. 3227

Jalima Quintero

Role: backup

Jalima.Quintero@va.gov

3059928621

Zaid M Abdelsattar, MD

Role: primary

Zaid.Abdelsattar@va.gov

Eliza Kintanar, RN

Role: backup

Eliza.Kintanar@va.gov

Catherine Sears, MD

Role: primary

Catherine.Sears@va.gov

Sharon Henson, RN

Role: backup

Sharon.Henson@va.gov

Janaki Deepak, MD

Role: primary

Janaki.Deepak@va.gov

410-605-7000

Ma Inez A Ambata, MSN

Role: backup

MaInezAmparo.Ambata@va.gov

Ronald Goldstein, MD

Role: primary

Ronald.Goldstein@va.gov

857-203-6478

Kathleen Lacerda

Role: backup

Kathleen.Lacerda@va.gov

8572036295

Jane Deng, MD

Role: primary

Jane.Deng@va.gov

734-845-3039

David Elliott, MD

Role: backup

David.Elliott1@va.gov

7348453914

Erin Wetherbee, MD

Role: primary

Erin.Wetherbee.@va.gov

Taira Miller

Role: backup

Taira.Miller1@va.gov

Scott Shofer, MD

Role: primary

Scott.Shofer@va.gov

Melissa A Wagner, BS

Role: backup

Melissa.Wagner2@va.gov

9192860411 ext. 7599

Charles Nock, MD

Role: primary

Charles.Nock@va.gov

216-791-3800 ext. 64825

Lisa Tucker

Role: backup

Lisa.Tucker@va.gov

2167913800 ext. 63595

Lorraine Cornwell, MD

Role: primary

Lorraine.Cornwell@va.gov

Adriana M Rueda, MS

Role: backup

Adriana.Rueda@va.gov

7137947459

Uzair Ghori, MD

Role: primary

Uzair.Ghori@va.gov

414-384-2000 ext. 42593

Kayla Neuendorf, BSN

Role: backup

Kayla.Neuendorf@va.gov

References

Elbanna M, Shiue K, Edwards D, Cerra-Franco A, Agrawal N, Hinton J, Mereniuk T, Huang C, Ryan JL, Smith J, Aaron VD, Burney H, Zang Y, Holmes J, Langer M, Zellars R, Lautenschlaeger T. Impact of Lung Parenchymal-Only Failure on Overall Survival in Early-Stage Lung Cancer Patients Treated With Stereotactic Ablative Radiotherapy. Clin Lung Cancer. 2021 May;22(3):e342-e359. doi: 10.1016/j.cllc.2020.05.024. Epub 2020 Jun 2.

Reference Type: DERIVED

PMID: 32736936 (View on PubMed)

Other Identifiers

2005

Identifier Type: -

Identifier Source: org_study_id