Sequentielle Kombination einer Chemotherapie mit Gemcitabine/Oxaliplatin und photodynamischen Therapie beim fortgeschrittenen Gallengangskarzinom - GemOx-PDT

Phase 1

• Conditions: - advanced cholangiocarcinoma; MedDRA version: 9.1Level: LLTClassification code 10008594Term: Cholangiocarcinoma non-resectable

• Registration Number: EUCTR2008-001560-37-DE
• Lead Sponsor: Medizinische Fakultät der TU-München, vertreten durch den Dekan

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-05-14
• Study Completion: 2012-07-30
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

before study beginn:
- histological and/or cytological proven cholangiocarcinoma or cholangiocarcinoma specific findings in at least two diagnostic approaches (ERCP, PTCD, cholangioscopy, computed tomography, magnetic resonance tomography)
- biliary sticture with sufficient biliary drainage.
- non-resectable/non-operabel
- Karnofsky-Index > 60%
- age > 18 years
- informed conset

before chemotherapy:
- bilirubin < 5 mg/dl
- GOT/GPT < 5 upper limit of norm
- kreatinin < 2 upper limit of norm
- thrombozytes > 100 G/l
- neutrophile granulocytes > 2 G/l
- Hemoglobin > 9 g/dl
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- self expanding metal stent
- photodynamic therapy in patients history
- chemotherapy in patients history
- second malignant tumor
- porhyria
- pregnant and nursing woman
- child bearing potential
- peripheral sensory neuropathy
- oxaliplatin hypersensitivity
- gemcitabine hypersensitivity

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective of the trial is to evaluate the combination of Gemcitabien/Oxaliplatin and photodynamic therapy in patients with advanced cholangiocarcinoma. The combination of systemic and local theray might improve the clinical benefit of these patients. ;Secondary Objective: Secundary objectives are progression free suvival 12 months after study beginn, progression free interval, evaluation of toxicity, overall survival, and quality of life. ;Primary end point(s): The primary objective is progression free survival 6 months after study beginn.