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

Danish Oncological Lung Cancer Group

Status and phase: Terminated; Phase 3

Conditions: First-Line; Small Cell Lung Cancer; Extensive Disease

Treatments: Drug: topotecan + cisplatin; Drug: Etoposide + carboplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT00812266

DOLG7 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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

Enrollment: 281 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

• PS 4
• Inadequate organ function
• Uncontrolled infection
• Concomitant major medical contraindications

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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281 participants in 2 patient groups

A

Experimental group

Description:

Topotecan + cisplatin

Treatment:

Drug: topotecan + cisplatin

B

Active Comparator group

Description:

Etoposide + carboplatin

Treatment:

Drug: Etoposide + carboplatin