Amrubicin Study for Elderly Patients With Extensive-disease Small-cell Lung Cancer (ED-SCLC)
This study has been terminated.
Sponsor:
Dainippon Sumitomo Pharma
Information provided by:
Dainippon Sumitomo Pharma
ClinicalTrials.gov Identifier:
NCT00286169
First received: February 1, 2006
Last updated: August 9, 2010
Last verified: August 2010
| Tracking Information | |||||
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| First Received Date ICMJE | February 1, 2006 | ||||
| Last Updated Date | August 9, 2010 | ||||
| Start Date ICMJE | April 2006 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Overall survival | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00286169 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
Time to progression, Objective tumor response, QOL (EuroQOL, FACT-L-LCS), Frequency and severity of adverse events | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Amrubicin Study for Elderly Patients With Extensive-disease Small-cell Lung Cancer (ED-SCLC) | ||||
| Official Title ICMJE | Randomized Phase III Trial of Amrubicin Versus Carboplatin Plus Etoposide in Elderly Patients With Extensive-disease Small-cell Lung Cancer | ||||
| Brief Summary | The purpose of this study is to compare the efficacy and toxicity of amrubicin with carboplatin plus etoposide in elderly patients with extensive-disease small-cell lung cancer. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Small-cell Lung Cancer | ||||
| Intervention ICMJE | Drug: Amrubicin Hydrochloride | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Terminated | ||||
| Estimated Enrollment ICMJE | 130 | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 70 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Japan | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00286169 | ||||
| Other Study ID Numbers ICMJE | D0702002, JapicCTI-060203 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Dainippon Sumitomo Pharma | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Dainippon Sumitomo Pharma | ||||
| Verification Date | August 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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