Stage III Lung Non-Small Cell Cancer AJCC v7 | Study of Positron Emission Tomography and Computed Tomography in Guiding Radiation Therapy in Patients With Stage III Non-small Cell Lung Cancer
Stage III Lung Non-Small Cell Cancer AJCC v7 research study
What is the primary objective of this study?
This randomized phase II trial studies how well positron emission tomography (PET)/computed tomography (CT)-guided radiation therapy works compared to standard radiation therapy in treating patients with stage III non-small cell lung cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Using imaging procedures, such as PET and CT scans, to guide the radiation therapy, may help doctors deliver higher doses directly to the tumor and cause less damage to healthy tissue.
Who is eligible to participate?
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 American Joint Committee on Cancer (AJCC) stage IIIA or IIIB (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 (ACR) Imaging Core Laboratory (Lab) qualified facility - Absolute neutrophil count (ANC) >= 1,500 cells/mm^3 (within 2 weeks prior to registration on study) - Platelets >= 100,000 cells/mm^3 (within 2 weeks prior to registration on study) - Hemoglobin (Hgb) >= 10.0 g/dL (note: the use of transfusion or other intervention to achieve Hgb >= 10.0 g/dL is acceptable) (within 2 weeks prior to registration on study) - 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 Exclusion Criteria: - Patients with any component of small cell lung carcinoma are excluded - Patients with evidence of a malignant pleural or pericardial effusion are excluded - Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible) - Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable - Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields - Severe, active co-morbidity, defined as follows: - Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months - Transmural myocardial infarction within the last 6 months - Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration - Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration - Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol - Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol - Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception - Poorly controlled diabetes (defined as fasting glucose level > 200 mg/dL) despite attempts to improve glucose control by fasting duration and adjustment of medications; patients with diabetes will preferably be scheduled in the morning and instructions for fasting and use of medications will be provided in consultation with the patients' primary physicians - Patients with T4 disease with radiographic evidence of massive invasion of a large pulmonary artery and tumor causing significant narrowing and destruction of that artery are excluded
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Stage III Lung Non-Small Cell Cancer AJCC v7
Stage IIIA Lung Non-Small Cell Cancer AJCC v7
Stage IIIB Lung Non-Small Cell Cancer AJCC v7
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:18F-FluoromisonidazoleUndergo FMISO PET/CT (Correlative studies)
Procedure:Computed TomographyUndergo FDG PET/CT
Procedure:Computed TomographyUndergo FMISO PET/CT (Correlative studies)
Radiation:External Beam Radiation TherapyUndergo radiotherapy
Drug:Fludeoxyglucose F-18Undergo FDG PET/CT
Radiation:Image-Guided Adaptive Radiation TherapyUndergo individualized adaptive radiotherapy
Other:Laboratory Biomarker AnalysisCorrelative studies
Procedure:Positron Emission TomographyUndergo FDG PET/CT
Procedure:Positron Emission TomographyUndergo FMISO PET/CT (Correlative studies)
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Arm I (standard chemoradiotherapy)Patients undergo radiotherapy QD 5 days a week for 30 fractions. Patients also receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes once weekly for 6 weeks. Patients undergo FDG-PET/CT imaging between fractions 18 and 19.
Arm II (experimental chemoradiotherapy)Patients undergo an individualized dose of image-guided radiotherapy QD 5 days a week for 30 fractions and undergo 18 F FDG-PET/CT between fractions 18 and 19. Based on the scan results, patients undergo individualized adaptive radiotherapy for the final 9 fractions. Patients also receive paclitaxel and carboplatin as in Arm I.
Active, not recruiting
Start Date: February 22, 2012
Phase: Phase 2
Primary Outcome: Local-regional, progression-free (LRPF) rate (National Surgical Adjuvant Breast and Bowel Project [NSABP], Radiation Therapy Oncology Group [RTOG], Gynecologic Oncology Group [GOG] [NRG])
Secondary Outcome: Time to local-regional progression (NRG)
Study sponsors, principal investigator, and references
Principal Investigator: Feng-Ming (Spring) P Kong
Lead Sponsor: National Cancer Institute (NCI)
Collaborator: NRG Oncology