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. Drugs such as paclitaxel may make tumor cells more sensitive to radiation therapy. It is not yet known if combination chemotherapy followed by radiation therapy is more effective with or without paclitaxel in treating unresectable stage III non-small cell lung cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy followed by radiation therapy with or without paclitaxel in treating patients who have unresectable stage III non-small cell lung cancer.
OBJECTIVES: * Compare the overall survival rate of patients with unresectable stage III non-small cell lung cancer treated with paclitaxel and carboplatin or cisplatin followed by radiotherapy with or without concurrent paclitaxel. * Compare the 1-year survival rate and mean survival time in patients treated with these regimens. * Compare the objective response rate and local control in patients treated with these regimens. * Compare the tolerability of these regimens in these patients. * Compare the safety profile and toxicity of these regimens in these patients. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms. All patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes or cisplatin IV on day 1. Treatment repeats every 21 days for 2 courses. Patients then proceed to randomized treatment. * Arm I: Patients receive paclitaxel IV over 1 hour on day 1 and radiotherapy on days 1-5 of each week for 6 weeks. * Arm II: Patients receive radiotherapy 5 days a week for 7 weeks. Patients are followed every 3 months for 1 year, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 300 patients (150 per treatment arm) will be accrued for this study within 3 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Enrollment
300
Ospedale Civile di Asti
Asti, Italy
Centro di Riferimento Oncologico - Aviano
Aviano, Italy
Ospedali Riuniti di Bergamo
Bergamo, Italy
Spedali Civili di Brescia
Brescia, Italy
Civic Hospital of Carrara
Carrara, Italy
Ospedale Regionale A. Pugliese
Overall survival rate
One-year survival rate and mean survival time
Objective response rate and local control
Tolerability
Safety profile, in terms of acute and delayed toxicity
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Catanzaro, Italy
Ospedale Mariano Santo
Cosenza, Italy
Azienda Istituti Ospitalieri
Cremona, Italy
Ospedale Santa Croce
Cuneo, Italy
Ospedale Galliera Oncologia
Genoa, Italy
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