Clinical trial NCT00540735: Efficiency Evaluation of Photodynamic Therapy With Photofrin® on Unresectable Type III or IV Cholangiocarcinomas
Official title: Efficiency Evaluation of Photodynamic Therapy With Photofrin® on Unresectable Type III or IV Cholangiocarcinomas - A Prospective, Multicentric and Randomized Study.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Cholangiocarcinoma
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2007-10-08
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Patients' survival compared between both groups : PDT and non-PDT.
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: UH Amiens
city: Angers
country: France
facility: UH Angers
city: Clichy
country: France
facility: H Beaujon
city: Créteil
country: France
facility: UH Henri Mondor
city: Le Kremlin Bicêtre
country: France
facility: UH Kremlin Bicêtre
city: Lille
country: France
facility: UH Claude Huriez
city: Lyon
country: France
facility: Clinique Sainte Anne
city: Marseille
country: France
facility: UH La Timone
city: Marseille
country: France
facility: UH Marseille Nord
city: Metz
country: France
facility: H Metz-Thionville
city: Nantes
country: France
facility: UH Nantes
city: Paris
country: France
facility: Clinique du Trocadéro
city: Paris
country: France
facility: UH Cochin
city: Poitiers
country: France
facility: UH La Milétrie
city: Rouen
country: France
facility: UH Charles Nicolle
city: Strasbourg
country: France
facility: UH Hôpital Civil
city: Toulouse
country: France
facility: UH Purpan
city: Toulouse
country: France
facility: UH Rangueil
Study officials:
affiliation: UH Angers
name: Jean Boyer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: