Efficiency Evaluation of Photodynamic Therapy With Photofrin® on Unresectable Type III or IV Cholangiocarcinomas (CK/PDT)

February 3, 2010 updated by: University Hospital, Angers

Efficiency Evaluation of Photodynamic Therapy With Photofrin® on Unresectable Type III or IV Cholangiocarcinomas - A Prospective, Multicentric and Randomized Study.

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

80

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France, 80 000
        • UH Amiens
      • Angers, France, 49933
        • UH Angers
      • Clichy, France, 92 118
        • H Beaujon
      • Créteil, France, 94 010
        • UH Henri Mondor
      • Le Kremlin Bicêtre, France, 94 275
        • UH Kremlin Bicêtre
      • Lille, France, 59 037
        • UH Claude Huriez
      • Lyon, France, 69 003
        • Clinique Sainte Anne
      • Marseille, France, 13 385
        • UH La Timone
      • Marseille, France, 13 915
        • UH Marseille Nord
      • Metz, France, 57 038
        • H Metz-Thionville
      • Nantes, France, 44 000
        • UH Nantes
      • Paris, France, 75 116
        • Clinique du Trocadero
      • Paris, France, 75 679
        • UH Cochin
      • Poitiers, France, 86 021
        • UH La Milétrie
      • Rouen, France, 76 031
        • UH Charles Nicolle
      • Strasbourg, France, 67 091
        • UH Hôpital Civil
      • Toulouse, France, 31 059
        • UH Purpan
      • Toulouse, France, 31 059
        • UH Rangueil

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 2
Experimental: 1
PDT
Procedure: photodynamic therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Patients' survival compared between both groups : PDT and non-PDT.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Investigators

  • Principal Investigator: Jean Boyer, MD, PhD, UH Angers

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Study Completion

November 1, 2009

Study Registration Dates

First Submitted

October 5, 2007

First Submitted That Met QC Criteria

October 5, 2007

First Posted (Estimate)

October 8, 2007

Study Record Updates

Last Update Posted (Estimate)

February 4, 2010

Last Update Submitted That Met QC Criteria

February 3, 2010

Last Verified

October 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHRC 2006-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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