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
1 other identifier
interventional
62
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 18, 2014
CompletedFirst Posted
Study publicly available on registry
December 23, 2014
CompletedDecember 30, 2014
December 1, 2014
11 months
December 18, 2014
December 29, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
progression-free survival
1 month
Study Arms (2)
Irinotecan and cisplatin
ACTIVE COMPARATORThe 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.
Etoposide and Cisplatin
ACTIVE COMPARATORThe 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.
Interventions
Eligibility Criteria
You may qualify if:
- Eastern Cooperative Oncology Group (ECOG) of 0 to 2
- A life expectancy of at least 3 months
- Measurable lesions
- Adequate hematologic function
You may not qualify if:
- Infection
- Myocardial infarction within the preceding three months
- Symptomatic brain metastases or receiving radiotherapy less than 4 weeks
- Pregnancy or breast-feeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chinese Academy of Medical Scienceslead
- China-Japan Friendship Hospitalcollaborator
- Chinese PLA General Hospitalcollaborator
Study Sites (1)
Cancer Institute/Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Beijing, Beijing Municipality, 100021, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
yuankai shi, PhD
Cancer Institute/Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
- PRINCIPAL INVESTIGATOR
xingsheng Hu
Cancer Institute/Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Cancer Institute/Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Study Record Dates
First Submitted
December 18, 2014
First Posted
December 23, 2014
Study Start
July 1, 2010
Primary Completion
June 1, 2011
Study Completion
June 1, 2012
Last Updated
December 30, 2014
Record last verified: 2014-12