Back to resultsA Study for Small Cell Lung Cancer (SCLC) in Extensive Disease Stage
Primary Purpose
Small Cell Lung Cancer
Status
Unknown status
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Carboplatin plus Irinotecan vs Carboplatin plus Etoposide
Sponsored by
About this trial
This is an interventional treatment trial for Small Cell Lung Cancer focused on measuring SCLC
Eligibility Criteria
Inclusion Criteria: cytological or histological proven SCLC Stage I or II at 1st diagnosis no prior chemotherapy measurable tumor disease karnofsky performance 70 Exclusion Criteria: second malignancy ( except basal cell carcinoma, CA in situ Cervix uteri) NYHA III chronic diarrhea, obstructive bowel syndrome
Sites / Locations
- Hematology & Oncology Charité CBF Berlin, GermanyRecruiting
Outcomes
Primary Outcome Measures
Primary Endpoint:
Documentation of the remission rate ( Phase II)
Determination of progress free time (Phase III)
Secondary Outcome Measures
Secondary Endpoint:
Documentation of progress free time (Phase II)
Documentation of objective remission rate ( Phase III)
Documentation of 1-year survival rate
Documentation of safety of the drug combination
Full Information
NCT ID
NCT00168896
First Posted
September 9, 2005
Last Updated
February 13, 2006
Sponsor
Charite University, Berlin, Germany
Collaborators
Pfizer, Aventis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00168896
Brief Title
A Study for Small Cell Lung Cancer (SCLC) in Extensive Disease Stage
Official Title
A Randomised Phase II/III Study to Compare the Combination of Carboplatin Plus Irinotecan Vs. the Combination of Carboplatin Plus Etoposide for SCLC in Extensive Disease Stage
Study Type
Interventional
2. Study Status
Record Verification Date
September 2001
Overall Recruitment Status
Unknown status
Study Start Date
October 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
Pfizer, Aventis Pharmaceuticals
4. Oversight
5. Study Description
Brief Summary
Comparison of two combination chemotherapies in the treatment of patients with SLCL
Detailed Description
Comparison of two combination chemotherapies in the treatment of patients with SLCL
The combination chemotherapies for this study are Carboplatin plus Irinotecan versus Carboplatin plus Etoposide.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Cancer
Keywords
SCLC
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
286 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Carboplatin plus Irinotecan vs Carboplatin plus Etoposide
Primary Outcome Measure Information:
Title
Primary Endpoint:
Title
Documentation of the remission rate ( Phase II)
Title
Determination of progress free time (Phase III)
Secondary Outcome Measure Information:
Title
Secondary Endpoint:
Title
Documentation of progress free time (Phase II)
Title
Documentation of objective remission rate ( Phase III)
Title
Documentation of 1-year survival rate
Title
Documentation of safety of the drug combination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
cytological or histological proven SCLC Stage I or II at 1st diagnosis
no prior chemotherapy
measurable tumor disease
karnofsky performance 70
Exclusion Criteria:
second malignancy ( except basal cell carcinoma, CA in situ Cervix uteri)
NYHA III
chronic diarrhea, obstructive bowel syndrome
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ulrich Keilholz, MD
Phone
+49-30-8445-3596
Email
ulrich.keilholz@charite.de
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander Schmittel, MD
Phone
+49-30-8445-3090
Email
alexander.schmittel @charite.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulrich Keilholz, MD
Organizational Affiliation
Charité Campus Benjamin Franklin University Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hematology & Oncology Charité CBF Berlin, Germany
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ulrich Keilholz, MD
Phone
+49-30-8445-3596
Email
ulrich.keilholz@charite.de
First Name & Middle Initial & Last Name & Degree
Alexander Schmittel, MD
Phone
+49-30-8445-3090
Email
alexander.schmittel@charite.de
First Name & Middle Initial & Last Name & Degree
Ulrich Keilholz, MD
12. IPD Sharing Statement
Learn more about this trial
A Study for Small Cell Lung Cancer (SCLC) in Extensive Disease Stage
We'll reach out to this number within 24 hrs