High-Dose or Standard-Dose Radiation Therapy and Chemotherapy With or Without Cetuximab in Treating Patients With Newly Diagnosed Stage III Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery
Trial ID or NCT#
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as paclitaxel, carboplatin work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether high-dose radiation therapy is more effective than standard-dose radiation therapy when given together with combination chemotherapy with or without cetuximab in treating patients with non-small cell lung cancer. PURPOSE: This randomized phase III trial is studying high-dose or standard-dose radiation therapy given together with chemotherapy with or without cetuximab to see how well they work in treating patients with newly diagnosed stage III non-small cell lung cancer that cannot be removed by surgery.
A Randomized Phase III Comparison of Standard-Dose (60 Gy) Versus High-Dose (74 Gy) Conformal Radiotherapy With Concurrent and Consolidation Carboplatin/Paclitaxel +/- Cetuximab (IND #103444) in Patients With Stage IIIA/IIIB Non-Small Cell Lung Cancer
- 1. N3 supraclavicular disease; 2. Greater than minimal, exudative, or cytologically positive pleural effusions; 3. Involved contralateral hilar nodes (i.e. greater than 1.5 cm on short axis or positive on PET scan); 4. ≥ 10% weight loss within the past month; 5. Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years; non-invasive conditions such as carcinoma in situ of the breast, oral cavity, or cervix are all permissible. 6. Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable. 7. Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields; 8. Prior therapy that specifically and directly targets the epidermal growth factor receptor (EGFR) pathway; 9. Prior severe infusion reaction to a monoclonal antibody; 10. Severe, active co-morbidity, defined as follows: - Significant history of uncontrolled cardiac disease; i.e., uncontrolled hypertension, unstable angina, myocardial infarction within the last 6 months, uncontrolled congestive heart failure, and cardiomyopathy with decreased ejection fraction. - 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 within 30 days before registration; - Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; - Acquired Immune Deficiency Syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immuno-compromised patients. 11. Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic. 12. Any history of allergic reaction to paclitaxel or other taxanes, or to carboplatin; 13. Uncontrolled neuropathy grade 2 or greater regardless of cause.
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Cancer Clinical Trials Office