Veterans Affairs Lung Cancer Surgery Or Stereotactic Radiotherapy
Sponsored by VA Office of Research and Development
About this study
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 overa…
Where this study is enrolling (14)
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VA Long Beach Healthcare System, Long Beach, CA
Long Beach, California
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VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California
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Miami VA Healthcare System, Miami, FL
Miami, Florida
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Bay Pines VA Healthcare System, Pay Pines, FL
Bay Pines, Florida
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Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois
Show all 14 locations
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Richard L. Roudebush VA Medical Center, Indianapolis, IN
Indianapolis, Indiana
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Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland
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VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts
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VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan
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Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota
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Durham VA Medical Center, Durham, NC
Durham, North Carolina
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Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio
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Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas
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Clement J. Zablocki VA Medical Center, Milwaukee, WI
Milwaukee, Wisconsin
Who can participate
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
Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.
Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.
Trial data sourced from ClinicalTrials.gov.