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

January 23, 2016 updated by: Seppo W. Langer, Danish Oncological Lung Cancer Group

Randomized Phase III Trial of Topotecan and Cisplatin Versus Etoposide and Carboplatin in the Treatment of Patients With Previously Untreated Small Cell Lung Cancer and Extensive Disease

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Actual)

281

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark
        • Dept. Oncology, Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Topotecan + cisplatin
Drug: topotecan + cisplatin
topotecan IV 2 mg/sqm d1-3 + cisplatin IV 50 mg/sqm d3 q3W
Active Comparator: B
Etoposide + carboplatin
Drug: Etoposide + carboplatin
Etoposide 120 mg/sqm IV d 1-3 + carboplatin AUC 5 d1 q3W

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
2 years survival
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Response rates
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danish Oncological Lung Cancer Group

Investigators

  • Principal Investigator: Seppo W Langer, MD PhD, Dept. of Oncology, Rigshospitalet, Copenhagen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

December 19, 2008

First Submitted That Met QC Criteria

December 19, 2008

First Posted (Estimate)

December 22, 2008

Study Record Updates

Last Update Posted (Estimate)

January 26, 2016

Last Update Submitted That Met QC Criteria

January 23, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DOLG7 (Other Identifier: Danish Oncological Lung Cancer Group Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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