Veterans Affairs Lung Cancer Surgery Or Stereotactic Radiotherapy (VALOR)
Lung Neoplasm
About this trial
This is an interventional treatment trial for Lung Neoplasm focused on measuring 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
Eligibility Criteria
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 an invasive malignancy within the past 5 years, whether newly diagnosed or recurrent, excluding low-risk prostate cancer, non-melanoma skin cancers, and in-situ cancers
- 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
Sites / Locations
- VA Long Beach Healthcare System, Long Beach, CARecruiting
- VA Greater Los Angeles Healthcare System, West Los Angeles, CARecruiting
- Bay Pines VA Healthcare System, Pay Pines, FLRecruiting
- Miami VA Healthcare System, Miami, FLRecruiting
- Edward Hines Jr. VA Hospital, Hines, ILRecruiting
- Richard L. Roudebush VA Medical Center, Indianapolis, INRecruiting
- Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MDRecruiting
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MARecruiting
- VA Ann Arbor Healthcare System, Ann Arbor, MIRecruiting
- Minneapolis VA Health Care System, Minneapolis, MNRecruiting
- Durham VA Medical Center, Durham, NCRecruiting
- Louis Stokes VA Medical Center, Cleveland, OHRecruiting
- Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PARecruiting
- VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PARecruiting
- Michael E. DeBakey VA Medical Center, Houston, TXRecruiting
- Hunter Holmes McGuire VA Medical Center, Richmond, VA
- Clement J. Zablocki VA Medical Center, Milwaukee, WIRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Stereotactic radiotherapy
Surgery
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.