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Sponsored by: |
Korean Cancer Study Group |
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Information provided by: | Korean Cancer Study Group |
ClinicalTrials.gov Identifier: | NCT00818090 |
To assess the efficacy and safety of the regimen in previously untreated, unresectable invasive thymoma or thymic carcinoma
Condition | Intervention | Phase |
---|---|---|
Thymoma Thymic Carcinoma |
Drug: paclitaxel and cisplatin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Study of Paclitaxel and Cisplatin in Previously Untreated, Unresectable Invasive Thymoma or Thymic Carcinoma |
Estimated Enrollment: | 50 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | June 2013 |
Estimated Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
TP: Experimental
paclitaxel and cisplatin every 3 weeks
|
Drug: paclitaxel and cisplatin
paclitaxel and cisplatin every 3 weeks
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Se-Hoon Lee, MD, PhD | +82-2-2072-0832 | shlee119@snu.ac.kr |
Korea, Republic of | |
Seoul National University Hospital | Recruiting |
Seoul, Korea, Republic of | |
Principal Investigator: Dae Seog Heo, MD, PhD | |
Sub-Investigator: Se-Hoon Lee, MD, PhD | |
Sub-Investigator: Dong Wan Kim, MD, PhD |
Principal Investigator: | Dae Seog Heo, MD, PhD | Seoul National University |
Responsible Party: | Seoul National University Hospital ( Dae Seog Heo ) |
Study ID Numbers: | KCSG-LU08-03; CRCST-L-0003 |
Study First Received: | January 5, 2009 |
Last Updated: | January 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00818090 |
Health Authority: | Korea: Food and Drug Administration |
thymic epithelial tumor paclitaxel cisplatin thymic carcinoma invasive thymoma |
Thoracic Neoplasms Cisplatin Paclitaxel Thymoma |
Thymus Neoplasms Neoplasms, Glandular and Epithelial Carcinoma |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Mitosis Modulators Antimitotic Agents Pharmacologic Actions |
Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses Tubulin Modulators Antineoplastic Agents, Phytogenic Neoplasms, Complex and Mixed |