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โ† Trials
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Veterans Affairs Lung Cancer Surgery Or Stereotactic Radiotherapy

RecruitingNAAges 18 Years - anyAllVA Office of Research and Development
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: Inclusion Criteria for Screening * 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
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What it tests

  • Stereotactic Radiotherapy
  • Anatomic Pulmonary Resection
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Where

17 sites
VA Long Beach Healthcare System, Long Beach, CA
Long Beach, United States
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, United States
Bay Pines VA Healthcare System, Pay Pines, FL
Bay Pines, United States
Miami VA Healthcare System, Miami, FL
Miami, United States
Edward Hines Jr. VA Hospital, Hines, IL
Hines, United States
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Indianapolis, United States
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, United States
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, United States

โ€ฆand 9 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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