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

This study has been terminated.
(Big difficulties to enroll patients)
Sponsor:
Information provided by:
University Hospital, Angers
ClinicalTrials.gov Identifier:
NCT00540735
First received: October 5, 2007
Last updated: February 3, 2010
Last verified: October 2007
  Purpose

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.


Condition Intervention Phase
Cholangiocarcinoma
Procedure: photodynamic therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficiency Evaluation of Photodynamic Therapy With Photofrin® on Unresectable Type III or IV Cholangiocarcinomas - A Prospective, Multicentric and Randomized Study.

Further study details as provided by University Hospital, Angers:

Primary Outcome Measures:
  • Patients' survival compared between both groups : PDT and non-PDT.

Estimated Enrollment: 80
Study Start Date: April 2008
Estimated Study Completion Date: November 2009
Arms Assigned Interventions
Experimental: 1
PDT
Procedure: photodynamic therapy
No Intervention: 2

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00540735

Locations
France
UH Amiens
Amiens, France, 80 000
UH Angers
Angers, France, 49933
H Beaujon
Clichy, France, 92 118
UH Henri Mondor
Créteil, France, 94 010
UH Kremlin Bicêtre
Le Kremlin Bicêtre, France, 94 275
UH Claude Huriez
Lille, France, 59 037
Clinique Sainte Anne
Lyon, France, 69 003
UH Marseille Nord
Marseille, France, 13 915
UH La Timone
Marseille, France, 13 385
H Metz-Thionville
Metz, France, 57 038
UH Nantes
Nantes, France, 44 000
UH Cochin
Paris, France, 75 679
Clinique du Trocadéro
Paris, France, 75 116
UH La Milétrie
Poitiers, France, 86 021
UH Charles Nicolle
Rouen, France, 76 031
UH Hôpital Civil
Strasbourg, France, 67 091
UH Purpan
Toulouse, France, 31 059
UH Rangueil
Toulouse, France, 31 059
Sponsors and Collaborators
University Hospital, Angers
Investigators
Principal Investigator: Jean Boyer, MD, PhD UH Angers
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00540735     History of Changes
Other Study ID Numbers: PHRC 2006-01
Study First Received: October 5, 2007
Last Updated: February 3, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Cholangiocarcinoma
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on October 19, 2014