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Completed

NCT Number: NCT02323737

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

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.

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Key information

Conditions

Extensive-stage Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Thoracic Neoplasms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cancer Institute/Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

Beijing, Beijing Municipality, 100021, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Eastern Cooperative Oncology Group (ECOG) of 0 to 2
  • A life expectancy of at least 3 months
  • Measurable lesions
  • Adequate hematologic function

Exclusion criteria

  • Infection
  • Myocardial infarction within the preceding three months
  • Symptomatic brain metastases or receiving radiotherapy less than 4 weeks
  • Pregnancy or breast-feeding

Treatment and study plan

Irinotecan and cisplatin

Drug

Etoposide and cisplatin

Drug

Primary outcomes

  1. progression-free survival

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

Chinese Academy of Medical Sciences

Other

Collaborators

  • China-Japan Friendship Hospital
  • Chinese PLA General Hospital

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Dec 23, 2014
Registry last updated
Dec 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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