combination chemotherapy and computer-planned radiation therapy in treating patients with unresectable stage iii non-small cell lung cancer

Conditions: Lung Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. radiation therapy uses high-energy x-rays to damage tumor cells. computer systems that allow doctors to create a 3-dimensional picture of the tumor to plan treatment may result in more effective radiation therapy. it is not yet known which chemotherapy and/or radiation therapy regimen is more effective in treating non-small cell lung cancer. purpose: randomized phase ii trial to compare the effectiveness of different combination chemotherapy regimens and 3-dimensional radiation therapy in treating patients who have unresectable stage iii non-small cell lung cancer.

objectives: * compare the overall response rate, failure-free survival, and survival of patients with inoperable stage iiia or iiib non-small cell lung cancer treated with paclitaxel and carboplatin with concurrent 3-dimensional conformal radiotherapy (3-d xrt) vs gemcitabine and carboplatin with concurrent 3-d xrt. * compare the toxicity of these regimens in these patients. * compare the pattern of failure (locoregional vs distant failure) in patients treated with these regimens. * determine the feasibility of delivering 3-d xrt to patients in this multicenter study. outline: this is a randomized, multicenter study. patients are randomized to one of two treatment arms. * arm i: patients receive paclitaxel iv over 3 hours followed by carboplatin iv over 30 minutes on day 1. treatment repeats every 21 days for 2 courses. patients then receive paclitaxel iv over 1 hour followed by carboplatin iv over 30 minutes once weekly and 3-dimensional conformal radiotherapy (3-d xrt) once daily 5 days a week. treatment repeats weekly for 7 courses. * arm ii: patients receive gemcitabine iv over 30 minutes on days 1 and 8 followed by carboplatin iv over 30 minutes on day 1. treatment repeats every 21 days for 2 courses. patients then receive gemcitabine iv over 30 minutes twice weekly and 3-d xrt as in arm i. treatment repeats weekly for 7 courses. in both arms, treatment continues in the absence of disease progression. patients are followed every 2 months for 2 years, every 4 months for 2 years, and then annually for 2 years. projected accrual: a total of 82 patients (41 per treatment arm) will be accrued for this study within 9 months.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed non-small cell lung cancer (nsclc) * squamous cell carcinoma * adenocarcinoma, including bronchoalveolar cell carcinoma * large cell anaplastic carcinoma, including giant and clear cell carcinoma * inoperable stage iiia or iiib disease * no direct invasion of vertebral body * tumors adjacent to a vertebral body without bone invasion allowed if all gross disease can be encompassed in radiotherapy boost field * contralateral mediastinal disease (n3) allowed if all gross disease can be encompassed in radiotherapy boost field * no scalene, supraclavicular, or contralateral hilar node involvement * transudate, cytologically negative, non-bloody pleural effusion allowed if it can be encompassed in radiotherapy field * no exudative, bloody, or cytologically malignant pleural effusion * evidence of pleural effusion by chest ct scan but not chest x-ray that is too small to tap allowed * at least 1 unidimensionally measurable lesion * at least 20 mm by conventional techniques or * at least 10 mm by spiral ct scan * the following are not considered measurable disease: * bone lesions * leptomeningeal disease * ascites * pleural/pericardial effusion * abdominal masses that are not confirmed and followed by imaging techniques * cystic lesions * tumor lesions in a previously irradiated field patient characteristics: age: * 18 and over performance status: * ecog 0-1 life expectancy: * not specified hematopoietic: * granulocyte count at least 1,500/mm3 * platelet count at least 100,000/mm3 hepatic: * bilirubin less than 1.5 mg/dl * ast less than 2 times upper limit of normal renal: * creatinine clearance 20-130 ml/min for females * creatinine clearance 20-150 ml/min for males pulmonary: * fev1 at least 1.2 l other: * not pregnant or nursing * fertile patients must use effective contraception * no other currently active malignancy (defined as completed prior therapy and considered to be at less than 30% risk of relapse) except non-melanoma skin cancer prior concurrent therapy: biologic therapy: * not specified chemotherapy: * no prior chemotherapy for nsclc * no other concurrent chemotherapy endocrine therapy: * no concurrent hormonal therapy except steroids for adrenal failure or septic shock, hormones for non-disease-related conditions (e.g., insulin for diabetes), or glucocorticosteroids as antiemetics radiotherapy: * see disease characteristics * no prior radiotherapy for nsclc surgery: * at least 2 weeks since prior exploratory thoracotomy

Keywords: squamous cell lung cancer large cell lung cancer stage iiia non-small cell lung cancer stage iiib non-small cell lung cancer adenocarcinoma of the lung bronchoalveolar cell lung cancer