A Study for Small Cell Lung Cancer (SCLC) in Extensive Disease Stage
![]() |
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. |
ClinicalTrials.gov Identifier: NCT00168896 |
Recruitment Status
: Unknown
Verified September 2001 by Charite University, Berlin, Germany.
Recruitment status was: Recruiting
First Posted
: September 15, 2005
Last Update Posted
: February 14, 2006
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Small Cell Lung Cancer | Drug: Carboplatin plus Irinotecan vs Carboplatin plus Etoposide | Phase 2 Phase 3 |
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 : | Interventional (Clinical Trial) |
Enrollment : | 286 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 Start Date : | October 2001 |
Study Completion Date : | December 2006 |

- Primary Endpoint:
- Documentation of the remission rate ( Phase II)
- Determination of progress free time (Phase III)
- 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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): NCT00168896
Contact: Ulrich Keilholz, MD | +49-30-8445-3596 | ulrich.keilholz@charite.de | |
Contact: Alexander Schmittel, MD | +49-30-8445-3090 | alexander.schmittel @charite.de |
Germany | |
Hematology & Oncology Charité CBF Berlin, Germany | Recruiting |
Berlin, Germany, 12203 | |
Contact: Ulrich Keilholz, MD +49-30-8445-3596 ulrich.keilholz@charite.de | |
Contact: Alexander Schmittel, MD +49-30-8445-3090 alexander.schmittel@charite.de | |
Principal Investigator: Ulrich Keilholz, MD |
Principal Investigator: | Ulrich Keilholz, MD | Charité Campus Benjamin Franklin University Clinic |
ClinicalTrials.gov Identifier: | NCT00168896 History of Changes |
Other Study ID Numbers: |
Haema CBF SCLC UK/AS 01 |
First Posted: | September 15, 2005 Key Record Dates |
Last Update Posted: | February 14, 2006 |
Last Verified: | September 2001 |
Keywords provided by Charite University, Berlin, Germany:
SCLC |
Additional relevant MeSH terms:
Lung Diseases Respiratory Tract Diseases Lung Neoplasms Small Cell Lung Carcinoma Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Irinotecan |
Etoposide phosphate Carboplatin Etoposide Antineoplastic Agents Antineoplastic Agents, Phytogenic Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Topoisomerase II Inhibitors |