Efficiency Evaluation of Photodynamic Therapy With Photofrin® on Unresectable Type III or IV Cholangiocarcinomas

Phase 3

Terminated

• Conditions: Cholangiocarcinoma
• Interventions: Procedure: photodynamic therapy

• Registration Number: NCT00540735
• Lead Sponsor: University Hospital, Angers

Brief Summary

Unresectable type III or IV cholangiocarcinoma has a very bad prognosis; survival median ranges between 6 and 9 months.

Survival depends on biliary drainage quality, obtained by plastic or metallic prothesis setting up in one or several hepatic segments.

Radiotherapy and/or chemotherapy didn't prove yet their efficiency on survival. In France, gemcitabin is recommended by the French Digestive Oncology Federation in metastatic tumours, in monotherapy or associated with cisplatin or oxaliplatin (Gemox) for patients in good general condition.

Photodynamic therapy has shown in 3 prospective studies - one randomized - with small patient series, a significative efficiency on survival and quality of life of treated patients, in comparison with historical series, or patients' groups whose biliary drainage was in most cases unefficient.

A new randomized study, including patients whose biliary drainage is efficient and comparing their becoming when they are treated by PDT in addition to current practice, or only by current practice, seems to be justified.

The principal objective of this study is to evaluate the efficiency of PDT with Photofrin® on patients with unresectable type III or IV cholangiocarcinoma.

Detailed Description

Not available

Study Timeline

• Status Verified: 2007-10
• Study First Submitted: 2007-10-05
• Study First Submitted QC: 2007-10-05
• Study First Posted: 2007-10-08
• Study Start: 2008-04
• Study Completion: 2009-11
• Last Update Submitted: 2010-02-03
• Last Update Posted: 2010-02-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Obtention of a written informed consent.
• Patient over 18.
• Patient with a type III or IV (according to Bismuth classification) histologically proved cholangiocarcinoma ; histologic diagnosis must be proved by biliary brushing, bile cytology, endobiliary biopsy under scope control with pediatric pliers, or by cytologic puncture under scan or echoendscopic control.
• Patient with Karnofsky score ≥ 50 %
• Patient with an efficient initial biliary drainage with prothesis.
• Cancer classified maximum T3N1M1, but only with intrahepatic metastasis occupying less than 25% of hepatic parenchyme (according to TNM cancer classification of extrahepatic biliary ducts' cancers).
• Patient capable of fill in the quality of life questionnaire.

Exclusion Criteria

• No written informed consent.
• Type I and II cholangiocarcinoma according to Bismuth classification.
• Patients with ASA score 4.
• Patients with clinical and biological signs of biliary infection.
• Patients with a severe visceral disease other than cholangiocarcinoma.
• Patients without an efficient initial biliary drainage.
• Patients with extrahepatic visceral metastasis, except perihilar ganglionic metastasis classified T4N1M+ according to TNM classification.
• Patients whose cholangiocarcinoma has already been resected.
• Patients under or already treated by radiotherapy or chemotherapy treatment for cholangiocarcinoma.
• Patients first treated with metallic prothesis.
• Patients with a contraindication to MRI.
• Patients with porphyria or hypersensibility to porphyrins.
• Patient treated by a non authorized treatment at the time of inclusion.
• Pregnant, parturient or breastfeeding women.
• Non menopaused woman without an efficient contraception.
• Patient under 18.
• Person over 18 under protection according to French Public Health Code.
• Person not affiliated to a social security regimen, or benefiting from such a regimen.
• Person in a exclusion period of another biomedical study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	photodynamic therapy	PDT

Primary Outcome Measures

Name	Time	Method
Patients' survival compared between both groups : PDT and non-PDT.

Trial Locations

Locations (18)

H Beaujon; 🇫🇷 Clichy, France

UH Claude Huriez; 🇫🇷 Lille, France

UH Marseille Nord; 🇫🇷 Marseille, France

UH Nantes; 🇫🇷 Nantes, France

Clinique Sainte Anne; 🇫🇷 Lyon, France

UH Henri Mondor; 🇫🇷 Créteil, France

H Metz-Thionville; 🇫🇷 Metz, France

UH Angers; 🇫🇷 Angers, France

UH La Timone; 🇫🇷 Marseille, France

Clinique du Trocadéro; 🇫🇷 Paris, France

UH Amiens; 🇫🇷 Amiens, France

UH La Milétrie; 🇫🇷 Poitiers, France

UH Kremlin Bicêtre; 🇫🇷 Le Kremlin Bicêtre, France

UH Cochin; 🇫🇷 Paris, France

UH Charles Nicolle; 🇫🇷 Rouen, France

UH Hôpital Civil; 🇫🇷 Strasbourg, France

UH Purpan; 🇫🇷 Toulouse, France

UH Rangueil; 🇫🇷 Toulouse, France