Study Of Irinotecan Hydrochloride (Campto(R)) And Cisplatin Versus Etoposide And Cisplatin In Small Cell Lung Cancer
NCT00143455
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- Histologically or cytologically proven Small Cell Lung Cancer (SCLC)
- WHO performance status : 0, 1
- No previous radiotherapy is allowed except on bone metastases when newly diagnosed.
Radiotherapy is not allowed for vena cava syndrome, a stent is recommended ;
- No prior surgery on the primary tumor except for palliative purpose (stent for vena
cava syndrome).
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Descriptive Information | ||||
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Brief Title ICMJE | Study Of Irinotecan Hydrochloride (Campto(R)) And Cisplatin Versus Etoposide And Cisplatin In Small Cell Lung Cancer | |||
Official Title ICMJE | Open Label, Randomised Multicentre Phase III Study Of Irinotecan Hydrochloride (Campto (Registered)) And Cisplatin Versus Etoposide And Cisplatin In Chemotherapy Naive Patients With Extensive Disease - Small Cell Lung Cancer | |||
Brief Summary | To compare the effects of irinotecan hydrochloride with cisplatin to the "standard" regimen etoposide plus cisplatin on overall survival, in chemotherapy-naive patients with newly diagnosed Extensive Disease-Small Cell Lung Cancer (ED-SCLC). | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Small Cell Lung Carcinoma | |||
Intervention ICMJE |
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Study Arms ICMJE |
| |||
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 | Completed | |||
Actual Enrollment ICMJE | 485 | |||
Original Enrollment ICMJE | 404 | |||
Actual Study Completion Date ICMJE | December 2008 | |||
Actual Primary Completion Date | December 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 | Austria, Belgium, Czech Republic, Egypt, France, Germany, Italy, Netherlands, Poland, Russian Federation, Spain, Switzerland, Taiwan | |||
Removed Location Countries | Ireland | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00143455 | |||
Other Study ID Numbers ICMJE | XRP4174D-3001 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer Inc | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | February 2010 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |