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Sponsored by: |
Asan Medical Center |
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Information provided by: | Asan Medical Center |
ClinicalTrials.gov Identifier: | NCT00869635 |
In patients with type III or IV cholangiocarcinoma, photodynamic therapy with biliary stent has been known for palliation of jaundice and improving survival. But most of therapeutic effects were expected to delay bile duct obstruction rather than to decrease the tumor. Recently orally available chemotherapeutic agent, S-1 was reported as effective in patients with bile duct adenocarcinoma. The investigators' aims of study evaluate the combined effect of photodynamic therapy and S-1.
Condition | Intervention | Phase |
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Cholangiocarcinoma |
Drug: S-1 Chemotherapy Procedure: Photodynamic therapy Procedure: Systemic chemotherapy except S-1 |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Photodynamic Therapy With S-1 in the Patients With Unresectable Type III or IV Cholangiocarcinoma: A Prospective Randomized Trial With Open Label Control |
Estimated Enrollment: | 110 |
Study Start Date: | February 2009 |
Estimated Study Completion Date: | February 2012 |
Estimated Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Treatment by combination of photodynamic therapy and S-1
100mg/day, ≧1.5m2: 120mg/day Given orally twice daily for 14days, followed by 7 days without treatment |
Drug: S-1 Chemotherapy
S-1 chemotherapy before intolerable complication or definite tumor progression Based on the body surface area, <1.25m2: 80mg/day, 1.25~1.5m2: 100mg/day, ≧1.5m2: 120mg/day Given orally twice daily for 14days, followed by 7 days without treatment
Procedure: Photodynamic therapy
PDT with Photofrin® 2mg/kg i.v. 48hrs before laser activation
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2: Active Comparator
Treatment by photodynamic therapy only
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Procedure: Photodynamic therapy
PDT with Photofrin® 2mg/kg i.v. 48hrs before laser activation
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3
Treatment by photodynamic therapy only or combined chemotherapy with photodynamic therapy: Open label
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Procedure: Photodynamic therapy
PDT with Photofrin® 2mg/kg i.v. 48hrs before laser activation
Procedure: Systemic chemotherapy except S-1
Variable systemic chemotherapy except S-1
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Ages Eligible for Study: | 18 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Do H Park, Prof. Dr. | 82-2-3010-3194 | dhpark@amc.seoul.kr |
Contact: Jun B Eum, Fellow Dr | 82-2-3010-3972 | mediperiment@gmail.com |
Korea, Republic of | |
Asan Medical Center | Recruiting |
Seoul, Korea, Republic of, 138-736 | |
Contact 82-2-1688-7575 webmaster@amc.seoul.kr | |
Sub-Investigator: Jun B Eum, Fellow Dr. | |
Principal Investigator: Do H Park, Prof. Dr. |
Responsible Party: | Department of Internal Medicine, Asan Medical Center ( Do-Hyun Park ) |
Study ID Numbers: | 2009-0056 |
Study First Received: | March 25, 2009 |
Last Updated: | March 26, 2009 |
ClinicalTrials.gov Identifier: | NCT00869635 History of Changes |
Health Authority: | Korea: Food and Drug Administration |
Cholangiocarcinoma Photodynamic therapy S-1 |
Cholangiocarcinoma Dihematoporphyrin Ether Hematoporphyrin Derivative Trioxsalen |
Adenocarcinoma Neoplasms, Glandular and Epithelial Carcinoma |
Cholangiocarcinoma Neoplasms Neoplasms by Histologic Type |
Adenocarcinoma Neoplasms, Glandular and Epithelial Carcinoma |