Adjuvant Cisplatin Plus Gemcitabine in Operable Cholangiocellular Carcinoma.
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|ClinicalTrials.gov Identifier: NCT01073839|
Recruitment Status : Completed
First Posted : February 23, 2010
Last Update Posted : September 18, 2015
The primary objective of the trial is to determine the safety of adjuvant treatment with cisplatin plus gemcitabine for a period of 6 months after curative resection of cholangiocellular carcinoma
Secondary objectives of the trial are to assess the feasibility and efficacy of the adjuvant therapy and to determine duration of response and patterns of failure compared to historical controls without postoperative treatment
To obtain blood samples and tumor tissue after resection for establishment and characterization of new cholangiocarcinoma cell lines and tumor antigens. Other aims are identification of tumor specific antibodies from blood samples, and characterization of tumor antigens with consecutive development of new specific immunological therapies, e.g. cancer-testis antigens (CTA) for tumor vaccination.
- Trial with medicinal product
|Condition or disease||Intervention/treatment||Phase|
|Cholangiocellular Carcinoma||Drug: Cisplatin and Gemcitabine||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Adjuvant Treatment of Resectable Cholangiocellular Carcinoma (CCC) With Cisplatin Plus Gemcitabine. A Prospective Single Center Phase Ib-II Study.|
|Study Start Date :||August 2008|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||August 2015|
Experimental: Cisplatin plus Gemcitabine
Patients after resection of cholangiocellular carcinoma will be allocated to treatment with cisplatin plus gemcitabine.
Drug: Cisplatin and Gemcitabine
Cisplatin 25 mg/m2 days 1 and 8; next cycle starting day 22. Gemcitabine 1000 mg/m2 days 1 and 8; next cycle starting day 22. Total of 8 cycles.
- Occurence of Grade 3 or 4 toxicities according to NCI-common terminology criteria for adverse events v3.0 [ Time Frame: One year ]
- Disease-free survival [ Time Frame: 5 years ]
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): NCT01073839
|Study Director:||01 Studienregister MasterAdmins||UniversitaetsSpital Zuerich|