NCT02323737

Phase II Study of Irinotecan and Cisplatin in Extensive-stage Small Cell Lung Cancer

Cisplatin Combined With Irinotecan or Etoposide for Untreated Extensive-stage Small Cell Lung Cancer: a Multicenter Randomized Control Clinical Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Patients with untreated extensive-stage small cell lung cancer(SCLC) were randomly assigned to receive either irinotecan/cisplatin (IP) or etoposide/cisplatin(EP), The association of efficacy and toxicity of IP regimen was analyzed.

Detailed description

This is a randomized, multicenter study. Patients are randomized to irinotecan/cisplatin (IP) or etoposide/cisplatin (EP) treatment arms. The IP regimen consisted of at most 6 cycles of irinotecan 65 mg/m2 of body-surface area on days 1, 8 and cisplatin 75mg/m2 of body-surface area on day 1. The EP regimen consisted of at most 6 cycles of etoposide 100 mg/m2 of body-surface area from day 1 to 3 and cisplatin 75mg/m2 of body-surface area on day 1. Cycle length for the two arms was 3 weeks. The dose adjustment was allowed in at most within ±5% per investigator discretion if necessary.

Conditions

• Extensive-stage Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Irinotecan and cisplatin
DRUG	Etoposide and cisplatin

Timeline

• Start date: 2010-07-01
• Primary completion: 2011-06-01
• Completion: 2012-06-01
• First posted: 2014-12-23
• Last updated: 2014-12-30

Locations

1 site across 1 country: China