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

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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