Calcitriol in Advanced Intrahepatic Cholangiocarcinoma
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|ClinicalTrials.gov Identifier: NCT01039181|
Recruitment Status : Unknown
Verified December 2009 by National Science and Technology Development Agency, Thailand.
Recruitment status was: Not yet recruiting
First Posted : December 24, 2009
Last Update Posted : December 24, 2009
|Condition or disease||Intervention/treatment||Phase|
|Advanced Intrahepatic Cholangiocarcinoma||Drug: Calcitriol||Phase 2|
- OUTLINE: This is a dose-limiting toxicity study of calcitriol.
- EVALUAITON: During the initial phase, 14 patients will be accrued for this study. If the number of patient's response to calcitriol and 5-fluorouracil/mitomycin C/leucovorin is less than 1/14, the study will be stopped. However there is one patient who responses to calcitriol and 5-fluorouracil/mitomycin C/leucovorin, the new 14 patients will be accrued during the secondary phase of study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Clinical Trial Phase II of Calcitriol in Combination With 5-fluorouracil, Mitomycin C and Leucovorin in an Open Label-non-randomized Study to Evaluate the Tumor Response in Patients With Advanced Intrahepatic Cholangiocarcinoma|
|Study Start Date :||January 2010|
|Estimated Primary Completion Date :||October 2011|
|Estimated Study Completion Date :||October 2012|
- To assess safety and tolerability of calcitriol in combination with 5-fluorouracil/mitomycin C/leucovorin. [ Time Frame: 3-6 months ]
- To assess quality of life (QOL) of patients who are received calcitriol in combination with 5-fluorouracil/mitomycin C/leucovorin. [ Time Frame: 3-6 months ]
- To assess the response of calcitriol in combination with 5-fluorouracil/mitomycin C/leucovorin in patients with advanced intrahepatic cholangiocarcinoma. [ Time Frame: 3-6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01039181
|Contact: Vajarabhongsa Bhudisawasdi, MD||66-43-348393||JOEVAJARA@gmail.com|
|Contact: Sopit Wongkham, PhD||66-43-348386||Sopit@kku.ac.th|
|Srinagarind Hospital, Faculty of Medicine, Khon Kaen University||Not yet recruiting|
|Khon Kaen, Thailand, 40002|
|Contact: Vajarabhongsa Bhudisawasdi, MD 66-43-348393 JOEVAJARA@gmail.com|
|Contact: Sopit Wongkham, PhD 66-43-348386 Sopit@kku.ac.th|
|Principal Investigator: Vajarabhongsa Bhudisawasdi, MD|
|Principal Investigator:||Vajarabhongsa Bhudisawasdi, MD||Department of Surgery, Faculty of Medicine, Liver fluke and cholangiocarcinoma research center, Khon Kaen University|