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

NCT ID: NCT02323737

Last Updated: 2014-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2012-06-30

Brief Summary

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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

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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.

Conditions

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Extensive-stage Small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Irinotecan and cisplatin

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.

Group Type ACTIVE_COMPARATOR

Irinotecan and cisplatin

Intervention Type DRUG

Etoposide and Cisplatin

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.

Group Type ACTIVE_COMPARATOR

Etoposide and cisplatin

Intervention Type DRUG

Interventions

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Irinotecan and cisplatin

Intervention Type DRUG

Etoposide and cisplatin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China-Japan Friendship Hospital

OTHER

Sponsor Role collaborator

Chinese PLA General Hospital

OTHER

Sponsor Role collaborator

Chinese Academy of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Shi Yuankai

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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yuankai shi, PhD

Role: PRINCIPAL_INVESTIGATOR

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

xingsheng Hu

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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CH-L-022

Identifier Type: -

Identifier Source: org_study_id