patient with metastatic cholangiocarcinoma MedDRA version: 17.1 Level: LLT Classification code 10008594 Term: Cholangiocarcinoma non-resectable System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Xeloda
Product Name: xeloda
Product Code: EU/1/00/163/001
Pharmaceutical Form: Tablet
Trade Name: gemcitabin
Product Name: gemcitabin
Pharmaceutical Form: Infusion
Trade Name: Oxaliplat
Sponsors
Herlev University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Informed consent • Age > 18 years • Performance status 0-1 • Patient with histological cholangiocarcinoma or malign cells and a CT-scan in accordance to a cholangiocarcinoma. • The disease not suitable for surgery • Neutrofile granulocytes ? 1.5 x 109/l and thrombocytes ? 75 x 109/l • Bilirubine ? 2.0 x UNL (upper normal limit). • Creatinine-clearence ? 45 ml/min Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 70
Exclusion criteria
Exclusion criteria: • Other current or prior malignant disease in the past five years, except adequately treated and cured carcinoma in situ of the cervix or squamous cell carcinoma of the skin. • The patient is not allowed to participate in other clinical trials with antineoplastic treatment.. • Other severe medical conditions • Presence of diseases preventing oral therapy • Patients with uncontrolled infection • Pregnant or lactating women • Women capable of childbearing not using a sufficient method of birth control • Patients not able to understand the treatment or to collaborate • Known prior hypersensitivity reactions to the agents
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Progression free survival ;Secondary Objective: Tumour response (RECIST version 1.1) b) Survival c) Toxicity ;Primary end point(s): Primary endpoint Progression free survival ;Timepoint(s) of evaluation of this end point: six month after last patient were included in the trial | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints a) Tumour response (RECIST version 1.1) b) Survival c) Toxicity ;Timepoint(s) of evaluation of this end point: 6 month after last patient were included in the trial | — |
Countries
Denmark
Contacts
Public ContactOncology Department
Herlev University Hospital
Outcome results
None listed