Randomized phase II study of irinotecan and cisplatin or irinotecan, cisplatin and etoposide in patients with extensive small-cell lung cancer

UMIN ID: C000000120

Registered date:01/06/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Extensive small-cell lung cancer
• Date of first enrollment: 2002/03/01
• Target sample size: 110
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Cisplatin 60 mg/m2 day 1 and irinotecan 60 mg/m2 days 1 and 8 were administered every 3 weeks for four cycles.
Cisplatin 60 mg/m2 day 1, irinotecan 60 mg/m2 days 1 and 8 and etoposide 50 mg/m2 days 1-3 were administered every 3 weeks for four cycles with prophylactic granulocyte colony-stimulating factor support.

Outcome(s)

• Primary Outcome: median survival time

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 70years-old
• Gender: Male and Female
• Exclude criteria: 1) uncontrollable pleural, pericardial effusion or ascites; 2) symptomatic brain metastasis; 3) active infection;4) contraindications for the use of irinotecan, including diarrhea, ileus, interstitial pneumonitis and lung fibrosis; 5) synchronous active malignancies; 6) serious concomitant medical illness, including severe heart disease, uncontrollable diabetes mellitus or hypertension; or 7) pregnancy or breast feeding.

Related Information

• Primary Sponsor: Division of Medical Oncology, National Cancer Center Hospital
• Source(s) of Monetary Support: Division of Policy-Based Medical Service Planning, National Cancer Center