RTOG1106 - ACRIN6697

Study Description: This randomized phase II trial studies how well positron emission tomography (PET)/computed tomography (CT) scan work in guiding radiation therapy compared to standard radiation therapy treatment in patients with stage III non-small cell lung cancer. Imaging procedures, such as PET scan and CT scan, may help doctors plan radiation therapy for patients with non-small cell lung cancer.

Contact for Enrollment

     (706) 721-0660

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Principal Investigator: Sharad Ghamande

Eligibility Criteria: Ages Eligible for Study: 18 Years and older Genders Eligible for Study: Both Accepts Healthy Volunteers: No Criteria Inclusion Criteria: Patients must have FDG-avid (maximum SUV >= 4.0) (from PET scan of any date, any scanner) and histologically or cytologically proven non-small cell lung cancer Patients must be clinical stage IIIA or IIIB (American Joint Committee on Cancer [AJCC], 7th ed.) with non-operable disease; non-operable disease will be determined by a multi-disciplinary treatment team, involving evaluation by at least 1 thoracic surgeon within 8 weeks prior to registration; Note: For patients who are clearly nonresectable, the case can be determined by the treating radiation oncologist and a medical oncologist, or pulmonologist Patients with multiple, ipsilateral pulmonary nodules (T3 or T4) are eligible if a definitive course of daily fractionated radiation therapy (RT) is planned History/physical examination, including documentation of weight, within 2 weeks prior to registration FDG-PET/CT scan for staging and RT plan within 4 weeks prior to registration CT scan or sim CT of chest and upper abdomen (IV contrast is recommended unless medically contraindicated) within 6 weeks prior to registration CT scan of the brain (contrast is recommended unless medically contraindicated) or MRI of the brain within 6 weeks prior to registration Pulmonary function tests, including diffusion capacity of carbon monoxide (DLCO), within 6 weeks prior to registration; patients must have forced expiratory volume in 1 second (FEV1) >= 1.2 Liter or >= 50% predicted without bronchodilator Zubrod performance status 0-1 Able to tolerate PET/CT imaging required to be performed at an American College of Radiology Imaging Network (ACRIN) qualified facility Absolute neutrophil count (ANC) >= 1,500 cells/mm^3 Platelets >= 100,000 cells/mm^3 Hemoglobin (Hgb) >= 10.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb >= 10.0 g/dl is acceptable) Serum creatinine within normal institutional limits or a creatinine clearance >= 60 ml/min within 2 weeks prior to registration Negative serum or urine pregnancy test within 3 days prior to registration for women of childbearing potential Women of childbearing potential and male participants must agree to use a medically effective means of birth control throughout their participation in the treatment phase of the study The patient must provide study-specific informed consent prior to study entry

Compensation: No, subjects will not be compensated.


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