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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-001560-37-DE

Enrollment

Registered

2008-05-14

Start date

Unknown

Completion date

Unknown

Last updated

2022-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Trade Name: Photofrin Product Name: Photofrin Pharmaceutical Form: Solution for injection INN or Proposed INN: Photofrin Concentration unit: mg/kg milligram(s)/kilogram Concentration type: equal Conc

Eligibility

Sex/Gender

All

Inclusion criteria

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 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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Germany

Outcome results