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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | August 14, 2002 | ||||
| Last Updated Date | May 15, 2009 | ||||
| Start Date ICMJE | August 2002 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Response rate | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00043862 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Time to Progression, response duration, survival, quantitative and qualitative assessment of tolerability | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Study Of An Oral Drug Called A Radiation Sensitizer In Patients With Newly Diagnosed Small Cell Lung Cancer (SCLC) | ||||
| Official Title ICMJE | A Phase II Trial of Twice Daily Oral Topotecan as a Radiation Sensitizer With Twice Daily Radiotherapy for Newly Diagnosed Small Cell Lung Cancer | ||||
| Brief Summary | This study will gather information on the effectiveness and safety of a treatment program for small cell lung cancer (SCLC) that uses an FDA approved chemotherapy combination, radiation therapy, and an oral investigational drug that may enhance the effects of radiation therapy. Study patients will receive two additional courses of the standard chemotherapy combination after completing radiation therapy. |
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| Detailed Description | |||||
| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Small Cell Lung Cancer | ||||
| Intervention ICMJE | Drug: topotecan | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 60 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00043862 | ||||
| Responsible Party | Study Director, GSK | ||||
| Study ID Numbers ICMJE | 104864/535 | ||||
| Study Sponsor ICMJE | GlaxoSmithKline | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | GlaxoSmithKline | ||||
| Verification Date | May 2009 | ||||
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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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