Topotecan and Cisplatin Versus Etoposide and Carboplatin in 1st Line Treatment of Patients With Small Cell Lung Cancer and Extensive Disease (SCLC-ED)

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

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

281 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2015-01-31

Brief Summary

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Randomised trial comparing standard chemotherapy with carboplatin and etoposide with a combination of topotecan and cisplatin in patients with inoperable lung cancer of small cell type.

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Detailed Description

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Fase III, multicenter randomised trial comparing up to six cycles of carboplatin and etoposide with up to six cycles of topotecan and cisplatin in patients with extensive stage small cell lung cancer and PS 0-3

Conditions

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Extensive Disease First-Line 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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A

Topotecan + cisplatin

Group Type EXPERIMENTAL

topotecan + cisplatin

Intervention Type DRUG

topotecan IV 2 mg/sqm d1-3 + cisplatin IV 50 mg/sqm d3 q3W

B

Etoposide + carboplatin

Group Type ACTIVE_COMPARATOR

Etoposide + carboplatin

Intervention Type DRUG

Etoposide 120 mg/sqm IV d 1-3 + carboplatin AUC 5 d1 q3W

Interventions

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topotecan + cisplatin

topotecan IV 2 mg/sqm d1-3 + cisplatin IV 50 mg/sqm d3 q3W

Intervention Type DRUG

Etoposide + carboplatin

Etoposide 120 mg/sqm IV d 1-3 + carboplatin AUC 5 d1 q3W

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histologically confirmed SCLC
* Extensive stage
* No prior chemotherapy
* WHO PS 0-3
* Adequate organ function (liver, kidney)
* Adequate hematology (bone marrow)
* Informed consent