A Study for Small Cell Lung Cancer (SCLC) in Extensive Disease Stage

NCT ID: NCT00168896

Last Updated: 2006-02-14

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

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

286 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-10-31

Study Completion Date

2006-12-31

Brief Summary

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Comparison of two combination chemotherapies in the treatment of patients with SLCL

Detailed Description

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Comparison of two combination chemotherapies in the treatment of patients with SLCL

The combination chemotherapies for this study are Carboplatin plus Irinotecan versus Carboplatin plus Etoposide.

Conditions

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Small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Carboplatin plus Irinotecan vs Carboplatin plus Etoposide

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* cytological or histological proven SCLC Stage I or II at 1st diagnosis
* no prior chemotherapy
* measurable tumor disease
* karnofsky performance 70

Exclusion Criteria

* second malignancy ( except basal cell carcinoma, CA in situ Cervix uteri)
* NYHA III
* chronic diarrhea, obstructive bowel syndrome
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

Aventis Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Principal Investigators

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Ulrich Keilholz, MD

Role: PRINCIPAL_INVESTIGATOR

Charité Campus Benjamin Franklin University Clinic

Locations

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Hematology & Oncology Charité CBF Berlin, Germany

Berlin, State of Berlin, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Ulrich Keilholz, MD

Role: CONTACT

+49-30-8445-3596

Alexander Schmittel, MD

Role: CONTACT

Facility Contacts

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Ulrich Keilholz, MD

Role: primary

+49-30-8445-3596

Alexander Schmittel, MD

Role: backup

+49-30-8445-3090

Other Identifiers

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Haema CBF SCLC UK/AS 01

Identifier Type: -

Identifier Source: org_study_id