Topotecan and Cisplatin Versus Etoposide and Carboplatin... | NCT00812266

ID	Type	Description	Link
DOLG7	Other Identifier	Danish Oncological Lung Cancer Group Number

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Slow accrual

Expanded Access Info

Start Date

Jan 2006

Primary Completion Date

Dec 2013Actual

Completion Date

Jan 2015Actual

First Submitted Date

Dec 19, 2008

First Submission Date that Met QC Criteria

Dec 19, 2008

First Posted Date

Dec 22, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 23, 2016

Last Update Posted Date

Jan 26, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Seppo W. Langer, MD pHD, Danish Oncological Lung Cancer GroupPrincipal Investigator

Lead Sponsor

Danish Oncological Lung Cancer GroupOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

281Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental	Topotecan + cisplatin	Drug: topotecan + cisplatin
B	Active Comparator	Etoposide + carboplatin	Drug: Etoposide + carboplatin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
topotecan + cisplatin	Drug	topotecan IV 2 mg/sqm d1-3 + cisplatin IV 50 mg/sqm d3 q3W	A

Measure	Description	Time Frame
2 years survival		2 years

Measure	Description	Time Frame
Response rates		2 years

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Seppo W Langer, MD PhD	Dept. of Oncology, Rigshospitalet, Copenhagen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept. Oncology, Rigshospitalet		Copenhagen			Denmark

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Term
D002166	Camptothecin
D000470	Alkaloids
D006571	Heterocyclic Compounds
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017672	Nitrogen Compounds
D017671	Platinum Compounds

ID	Term
D019772	Topotecan
D002945	Cisplatin
C098534	EC regimen