To evaluate whether two weekly concurrent chemoradiotherapy regimens offer any advantage over concurrent chemoradiotherapy regimens with Cisplatin, Vindesine, Mitomycin for unresectable stage III NSCLC

UMIN ID: C000000087

Registered date:29/08/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: unresectable stage III NSCLC
• Date of first enrollment: 2001/10/01
• Target sample size: 450
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

arm A : The chemotherapy regimen consist of Cisplatin 80mg/m2 on day1 AND 29, Vindesine 3mg/m2 on day1,8, 29, and 36, Mitomycin 8mg/m2 on day1 and 29. The concurrent radiation consists of two, 30 gray courses separated by a 7-day rest period. Patients receive 2 courses of chemotherapy consist of Cisplatin, Vindesine, and Mitomycin as consolidation chemotherapy.
arm B: The chemotherapy regimen consists of Irinotecan 20mg/m2 and Carboplatin AUC2 administered weekly for 6 weeks. The concurrent radiation consists of 60 gray. Patients receive 2 courses of chemotherapy consist of Irinotecan and Carboplatin as consolidation chemotherapy.
arm C: The chemotherapy regimen consists of Paclitaxel 40mg/m2 and Carboplatin AUC2 administered weekly for 6 weeks. The concurrent radiation consists of 60 gray. Patients receive 2 courses of chemotherapy consist of Paclitaxel and Carboplatin as consolidation chemotherapy.

Outcome(s)

• Primary Outcome: Survival

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: The exclusion criteria consisted of pulmonary fibrosis, pleural effusion, pregnancy, lactation, active concurrent malignancies, severe drug allergies, myocardial infarction, severe heart disease, uncontrollable diabetes mellitus, and infection.

Related Information

• Primary Sponsor: West Japan Oncology Group
• Source(s) of Monetary Support: None