Paclitaxel and Cisplatin for Thymic Neoplasm
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ClinicalTrials.gov Identifier: NCT00818090 |
Recruitment Status :
Terminated
(marginal statistical significance)
First Posted : January 7, 2009
Last Update Posted : April 12, 2013
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Sponsor:
Korean Cancer Study Group
Information provided by (Responsible Party):
Se-Hoon Lee, Korean Cancer Study Group
Tracking Information | ||||
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First Submitted Date ICMJE | January 5, 2009 | |||
First Posted Date ICMJE | January 7, 2009 | |||
Last Update Posted Date | April 12, 2013 | |||
Study Start Date ICMJE | September 2008 | |||
Actual Primary Completion Date | November 2011 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Response rate [ Time Frame: 6 weeks, 12 weeks, 18 weeks ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Paclitaxel and Cisplatin for Thymic Neoplasm | |||
Official Title ICMJE | A Phase II Study of Paclitaxel and Cisplatin in Previously Untreated, Unresectable Invasive Thymoma or Thymic Carcinoma | |||
Brief Summary | To assess the efficacy and safety of the regimen in previously untreated, unresectable invasive thymoma or thymic carcinoma | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Drug: paclitaxel and cisplatin
paclitaxel and cisplatin every 3 weeks
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Study Arms ICMJE | Experimental: TP
paclitaxel and cisplatin every 3 weeks
Intervention: Drug: paclitaxel and cisplatin
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Publications * | Not Provided | |||
* 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 | |||
Actual Enrollment ICMJE |
39 | |||
Original Estimated Enrollment ICMJE |
50 | |||
Actual Study Completion Date ICMJE | November 2011 | |||
Actual Primary Completion Date | November 2011 (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 and older (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 | Korea, Republic of | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00818090 | |||
Other Study ID Numbers ICMJE | KCSG-LU08-03; CRCST-L-0003 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Se-Hoon Lee, Korean Cancer Study Group | |||
Study Sponsor ICMJE | Korean Cancer Study Group | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Korean Cancer Study Group | |||
Verification Date | September 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |