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

This study has been terminated.
(Slow accrual)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00812266
First Posted: December 22, 2008
Last Update Posted: January 26, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Seppo W. Langer, Danish Oncological Lung Cancer Group
  Purpose
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.

Condition Intervention Phase
Extensive Disease First-Line Small Cell Lung Cancer Drug: topotecan + cisplatin Drug: Etoposide + carboplatin Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Seppo W. Langer, Danish Oncological Lung Cancer Group:

Primary Outcome Measures:
  • 2 years survival [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • Response rates [ Time Frame: 2 years ]

Enrollment: 281
Study Start Date: January 2006
Study Completion Date: January 2015
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00812266


Locations
Denmark
Dept. Oncology, Rigshospitalet
Copenhagen, Denmark
Sponsors and Collaborators
Danish Oncological Lung Cancer Group
Investigators
Principal Investigator: Seppo W Langer, MD PhD Dept. of Oncology, Rigshospitalet, Copenhagen
  More Information

Responsible Party: Seppo W. Langer, MD pHD, Danish Oncological Lung Cancer Group
ClinicalTrials.gov Identifier: NCT00812266     History of Changes
Other Study ID Numbers: DOLG7
DOLG7 ( Other Identifier: Danish Oncological Lung Cancer Group Number )
First Submitted: December 19, 2008
First Posted: December 22, 2008
Last Update Posted: January 26, 2016
Last Verified: January 2016

Keywords provided by Seppo W. Langer, Danish Oncological Lung Cancer Group:
SCLC
Extensive disease
topotecan

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Etoposide phosphate
Cisplatin
Carboplatin
Etoposide
Topotecan
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Topoisomerase I Inhibitors