Adjuvant Cisplatin Plus Gemcitabine in Operable Cholangiocellular Carcinoma.
- Registration Number
- NCT01073839
- Lead Sponsor
- University of Zurich
- Brief Summary
OBJECTIVES
Primary objective:
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:
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
Exploratory objectives:
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cisplatin plus Gemcitabine Cisplatin and Gemcitabine Patients after resection of cholangiocellular carcinoma will be allocated to treatment with cisplatin plus gemcitabine.
- Primary Outcome Measures
Name Time Method Occurence of Grade 3 or 4 toxicities according to NCI-common terminology criteria for adverse events v3.0 One year
- Secondary Outcome Measures
Name Time Method Disease-free survival 5 years