Dose-intensive weekly combination chemotherapy (cisplatin, vincristine, doxorubicin and etoposide) followed by cisplatin-etoposide therapy with concurrent thoracic irradiation: evaluation of a new treatment for limited-disease small-cell lung cancer.

UMIN ID: C000000145

Registered date:09/09/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: limited-disease small-cell lung cancer
• Date of first enrollment: 1996/06/01
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): The CODE treatment phase consisted of 25 mg/m2 cisplatin (i.v.) once a week for 4 weeks, 45 mg/m2 doxorubicin (i.v.) on day 1, 80 mg/m2 etoposide (i.v.) on days 1 through 3 during weeks 1 and 3, and 1 mg/m2 vincristine (i.v.) on day 1 during weeks 2 and 4. The PE treatment phase consisted of 80 mg/m2 cisplatin (i.v.) on day 1 and 100 mg/m2 etoposide on days 1 through 3. These treatments were repeated every 4 weeks for 3 cycles. Thoracic radiotherapy began on day 2 of the first PE cycle. Radiation was administered in twice-daily fractions separated by at least 4 hours. The total dose was 45 Gy, which administered in 30 fractions over 3 weeks.

Outcome(s)

• Primary Outcome: The primary endpoint was survival time and the secondary endpoints were the actual dose intensity, response rate, toxicity.

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: 70years-old
• Gender: Male and Female
• Exclude criteria: The criteria were age ≥ to 18 years and ≤ 70years, no concurrent active malignancies.

Related Information

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