Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01073839
Other study ID # ONK USZ 001-2008
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received June 25, 2009
Last updated September 17, 2015
Start date August 2008
Est. completion date August 2015

Study information

Verified date September 2015
Source University of Zurich
Contact n/a
Is FDA regulated No
Health authority Switzerland: Swissmedic
Study type Interventional

Clinical Trial 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


Read more »

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Occurence of Grade 3 or 4 toxicities according to NCI-common terminology criteria for adverse events v3.0 One year Yes
Secondary Disease-free survival 5 years No
See also
  Status Clinical Trial Phase
Completed NCT02156700 - Quantitative Real-time Ultrasound Elastography for Characterisation of Liver Tumors N/A
Completed NCT01320241 - Radiation Stent Versus Self-expanding Metallic Stents (SEMS) for Palliative Treatment of Malignant Biliary Stricture Phase 2
Active, not recruiting NCT01862315 - Hepatic Arterial Infusion (HAI) With Floxuridine (FUDR) and Dexamethasone (Dex) Combined With Systemic Gemcitabine and Oxaliplatin in Patients With Unresectable Intrahepatic Cholangiocarcinoma (ICC) Phase 2
Completed NCT02999672 - A Study to Determine Best Tumor Response With Trastuzumab Emtansine in Human Epidermal Growth Factor Receptor 2 (HER2) Overexpressing Solid Tumors Phase 2
Terminated NCT00832637 - Gemcitabine, Oxaliplatin, Tarceva &/or Cisplatin in HCC & Biliary Tree Cancers Phase 2
Completed NCT01692704 - Downsizing of Unresectable Cholangiocarcinoma by Combined Intravenous and Intra-arterial Chemotherapy Phase 1/Phase 2