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

Primary Purpose

Extensive-stage Small Cell Lung Cancer

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Irinotecan and cisplatin
Etoposide and cisplatin
Sponsored by
Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Extensive-stage Small Cell Lung Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Irinotecan and cisplatin

Etoposide and Cisplatin

Arm Description

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.

Outcomes

Primary Outcome Measures

progression-free survival

Secondary Outcome Measures

Full Information

First Posted
December 18, 2014
Last Updated
December 29, 2014
Sponsor
Chinese Academy of Medical Sciences
Collaborators
China-Japan Friendship Hospital, Chinese PLA General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02323737
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 Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences
Collaborators
China-Japan Friendship Hospital, Chinese PLA General Hospital

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extensive-stage Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Irinotecan and cisplatin
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Etoposide and Cisplatin
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Irinotecan and cisplatin
Intervention Type
Drug
Intervention Name(s)
Etoposide and cisplatin
Primary Outcome Measure Information:
Title
progression-free survival
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
yuankai shi, PhD
Organizational Affiliation
Cancer Institute/Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
xingsheng Hu
Organizational Affiliation
Cancer Institute/Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Institute/Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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