A Study for Small Cell Lung Cancer (SCLC) in Extensive Disease Stage

NCT00168896

Last updated date
Study Location
Hematology & Oncology Charité CBF Berlin, Germany
Berlin, , 12203, Germany
Contact
+49-30-8445-3596

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Small Cell Lung Cancer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- cytological or histological proven SCLC Stage I or II at 1st diagnosis

- no prior chemotherapy

- measurable tumor disease

- karnofsky performance 70

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- second malignancy ( except basal cell carcinoma, CA in situ Cervix uteri)


- NYHA III


- chronic diarrhea, obstructive bowel syndrome

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study for Small Cell Lung Cancer (SCLC) in Extensive Disease Stage
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Small Cell Lung Cancer
Intervention  ICMJE Drug: Carboplatin plus Irinotecan vs Carboplatin plus Etoposide
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE
 (submitted: September 9, 2005)
286
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE December 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00168896
Other Study ID Numbers  ICMJE Haema CBF SCLC UK/AS 01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Charite University, Berlin, Germany
Collaborators  ICMJE
  • Pfizer
  • Aventis Pharmaceuticals
Investigators  ICMJE
Principal Investigator:Ulrich Keilholz, MDCharité Campus Benjamin Franklin University Clinic
PRS Account Charite University, Berlin, Germany
Verification Date September 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP