A Phase III Study Comparing Irinotecan, Cisplatin and Etoposide (PEI) with Nogitecan for the Treatment of Relapsed Small-Cell Lung Cancer (JCOG0605)

UMIN ID: UMIN000000828

Registered date:20/09/2007

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Sensitive relpased small-cell lung cancer
• Date of first enrollment: 2007/09/01
• Target sample size: 180
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

A: nogitecan (1.0 mg/m2/day) on days 1 through 5 every 3 weeks, for 4 courses
B: irinotecan, cisplatin and etoposide (PEI) 1 course (2 weeks) consisted of cisplatin (25 mg/m2, day1, 8), etoposide (60 mg/m2, day1-3), and irinotecan (90 mg/m2, day8), for 5 courses. After day 8, granulocyte colony-stimulating factor (G-CSF) is administered routinely on days when the cytotoxic drugs are not given.

Outcome(s)

• Primary Outcome: overall survival
• Secondary Outcome: progression-free survival, adverse events, response rate

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1) no active concomitant malignancy 2) pregnancy or lactation 3) serious psychiatric illness 4) steroid treatment 5) massive pleural or pericardial effusion 6) symptomatic brain metastasis 7) interstitial pneumonia or severe pulmonary emphysema 8) diarrhea 9) ileus 10) myocardial infarction within 6 months or unstable angina 11) uncontrollable hypertension 12) uncontrollable diabetes mellitus 13) active infection

Related Information

• Primary Sponsor: Japan Clinical Oncology Group(JCOG)
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare