search
Back to results

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

Primary Purpose

Extensive Disease, First-Line, Small Cell Lung Cancer

Status
Terminated
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
topotecan + cisplatin
Etoposide + carboplatin
Sponsored by
Danish Oncological Lung Cancer Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Extensive Disease focused on measuring SCLC, Extensive disease, topotecan

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Dept. Oncology, Rigshospitalet

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A

B

Arm Description

Topotecan + cisplatin

Etoposide + carboplatin

Outcomes

Primary Outcome Measures

2 years survival

Secondary Outcome Measures

Response rates

Full Information

First Posted
December 19, 2008
Last Updated
January 23, 2016
Sponsor
Danish Oncological Lung Cancer Group
search

1. Study Identification

Unique Protocol Identification Number
NCT00812266
Brief Title
Topotecan and Cisplatin Versus Etoposide and Carboplatin in 1st Line Treatment of Patients With Small Cell Lung Cancer and Extensive Disease (SCLC-ED)
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Terminated
Why Stopped
Slow accrual
Study Start Date
January 2006 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Danish Oncological Lung Cancer Group

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extensive Disease, First-Line, Small Cell Lung Cancer
Keywords
SCLC, Extensive disease, topotecan

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
281 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Topotecan + cisplatin
Arm Title
B
Arm Type
Active Comparator
Arm Description
Etoposide + carboplatin
Intervention Type
Drug
Intervention Name(s)
topotecan + cisplatin
Intervention Description
topotecan IV 2 mg/sqm d1-3 + cisplatin IV 50 mg/sqm d3 q3W
Intervention Type
Drug
Intervention Name(s)
Etoposide + carboplatin
Intervention Description
Etoposide 120 mg/sqm IV d 1-3 + carboplatin AUC 5 d1 q3W
Primary Outcome Measure Information:
Title
2 years survival
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Response rates
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seppo W Langer, MD PhD
Organizational Affiliation
Dept. of Oncology, Rigshospitalet, Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. Oncology, Rigshospitalet
City
Copenhagen
Country
Denmark

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs