Spots Global Cancer Trial Database for Phase II Study of Irinotecan and Cisplatin in Extensive-stage Small Cell Lung Cancer

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Trial Identification

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

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

Study ID: NCT02323737

Conditions

Extensive-stage Small Cell Lung Cancer

Interventions

Irinotecan and cisplatin

Etoposide and cisplatin

Study Description

Brief 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.