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

NCT ID: NCT00540735

Last Updated: 2010-02-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2009-11-30

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.

Conditions

Cholangiocarcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

PDT

Group Type: EXPERIMENTAL

photodynamic therapy

Intervention Type: PROCEDURE

2

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

photodynamic therapy

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Angers

OTHER_GOV

Sponsor Role: lead

Principal Investigators

Jean Boyer, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UH Angers

Locations

UH Amiens

Amiens, , France

UH Angers

Angers, , France

H Beaujon

Clichy, , France

UH Henri Mondor

Créteil, , France

UH Kremlin Bicêtre

Le Kremlin-Bicêtre, , France

UH Claude Huriez

Lille, , France

Clinique Sainte Anne

Lyon, , France

UH La Timone

Marseille, , France

UH Marseille Nord

Marseille, , France

H Metz-Thionville

Metz, , France

UH Nantes

Nantes, , France

Clinique du Trocadéro

Paris, , France

UH Cochin

Paris, , France

UH La Milétrie

Poitiers, , France

UH Charles Nicolle

Rouen, , France

UH Hôpital Civil

Strasbourg, , France

UH Purpan

Toulouse, , France

UH Rangueil

Toulouse, , France

Countries

France

Other Identifiers

PHRC 2006-01

Identifier Type: -

Identifier Source: org_study_id