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
About this trial
This is an interventional treatment trial for Extensive-stage Small Cell Lung Cancer
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
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
NCT ID
NCT02323737
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
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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