Lung Cancer
Conditions
Keywords
stage IIIB non-small cell lung cancer
Brief 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. Combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy and radiation therapy before surgery in treating patients who have stage IIIB non-small cell lung cancer.
Detailed description
OBJECTIVES: * Determine the incidence of radically resected disease in patients with stage IIIB non-small cell lung cancer treated with induction cisplatin, etoposide, and radiotherapy followed by surgical resection. * Determine the toxicity (morbidity and mortality) of this regimen in these patients. * Determine the clinical response rate and pathological response rate in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive induction chemotherapy comprising cisplatin IV on day 1 and etoposide IV on days 1-3. Chemotherapy repeats every 3 weeks for 3 courses. Beginning on day 2 of the second course of chemotherapy, patients undergo induction radiotherapy once daily 5 days a week for 5-7 weeks. Chemoradiotherapy continues in the absence of disease progression or unacceptable toxicity. At 3-6 weeks after completion of the last dose of induction radiotherapy, patients undergo lobectomy or pneumonectomy. Patients are followed at 30 days and 4 months, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 27-62 patients will be accrued for this study.
Interventions
DRUGcisplatin
DRUGetoposide
PROCEDUREconventional surgery
RADIATIONradiation therapy
Sponsors
European Organisation for Research and Treatment of Cancer - EORTC
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed primary stage IIIB non-small cell lung cancer (NSCLC) * T4, any N, M0 or any T, N3, M0 * No N3 disease due to scalene or supraclavicular lymph node involvement * No primary tumors located in the lower lobe combined with contralateral upper higher mediastinal lymph node involvement * No mixed tumor types with small cell lung cancer * At least 1 unidimensionally measurable target lesion * At least 20 mm by conventional techniques OR * At least 10 mm by spiral CT scan * No pre-existing pleural or pericardial effusion * No CNS involvement by CT scan or MRI PATIENT CHARACTERISTICS: Age: * 18 to 75 Performance status: * WHO 0-1 Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 2,000/mm\^3 * Platelet count at least 100,000/mm \^3 Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * AST/ALT no greater than 1.5 times ULN * Alkaline phosphatase no greater than 2.5 times ULN Renal: * Creatinine no greater than 1.25 times ULN * Creatinine clearance at least 60 mL/min Cardiovascular: * No clinical evidence of superior vena cava syndrome Pulmonary: * Postoperative FEV1 and KCO greater than 40% predicted * VO2 max greater than 15 mL/min/kg (if postoperative KCO no greater than 40% predicted) Other: * No other primary malignancy except carcinoma in situ of the cervix, adequately treated basal cell skin cancer, or other malignancy treated more than 5 years ago without recurrence (excluding melanoma, breast cancer, or hypernephroma) * No active uncontrolled infection requiring IV antibiotics * No pre-existing sensory neurotoxicity grade 2 or greater * No psychological, familial, sociological, or geographical condition that would preclude study compliance * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior immunotherapy for NSCLC * No concurrent immunotherapy during induction chemoradiotherapy * Concurrent colony stimulating factors allowed Chemotherapy: * No prior chemotherapy for NSCLC Endocrine therapy: * No concurrent anticancer hormonal agents (except corticosteroids for antiemetic prophylaxis) during induction chemoradiotherapy Radiotherapy: * No prior radiotherapy for NSCLC Surgery: * No prior surgery for NSCLC Other: * No other concurrent anticancer drugs during induction chemoradiotherapy
Countries
Belgium, Germany, Netherlands, Poland
Outcome results
None listed