Brief Title
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.
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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Patients' survival compared between both groups : PDT and non-PDT.
Condition
Cholangiocarcinoma
Intervention
photodynamic therapy
Study Arms / Comparison Groups
1
Description: PDT
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
80
Start Date
April 2008
Completion Date
November 2009
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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Jean Boyer, MD, PhD, ,
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT00540735
Organization ID
PHRC 2006-01
Study Sponsor
University Hospital, Angers
Study Sponsor
Jean Boyer, MD, PhD, Principal Investigator, UH Angers
Verification Date
October 2007