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

Primary Purpose

Cholangiocarcinoma

Status
Terminated
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
photodynamic therapy
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cholangiocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UH Amiens
  • UH Angers
  • H Beaujon
  • UH Henri Mondor
  • UH Kremlin Bicêtre
  • UH Claude Huriez
  • Clinique Sainte Anne
  • UH La Timone
  • UH Marseille Nord
  • H Metz-Thionville
  • UH Nantes
  • Clinique du Trocadéro
  • UH Cochin
  • UH La Milétrie
  • UH Charles Nicolle
  • UH Hôpital Civil
  • UH Purpan
  • UH Rangueil

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

2

Arm Description

PDT

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 5, 2007
Last Updated
February 3, 2010
Sponsor
University Hospital, Angers
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1. Study Identification

Unique Protocol Identification Number
NCT00540735
Brief Title
Efficiency Evaluation of Photodynamic Therapy With Photofrin® on Unresectable Type III or IV Cholangiocarcinomas
Acronym
CK/PDT
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

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Terminated
Why Stopped
Big difficulties to enroll patients
Study Start Date
April 2008 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2009 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Angers

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholangiocarcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (false)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
PDT
Arm Title
2
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
photodynamic therapy
Primary Outcome Measure Information:
Title
Patients' survival compared between both groups : PDT and non-PDT.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Boyer, MD, PhD
Organizational Affiliation
UH Angers
Official's Role
Principal Investigator
Facility Information:
Facility Name
UH Amiens
City
Amiens
ZIP/Postal Code
80 000
Country
France
Facility Name
UH Angers
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Name
H Beaujon
City
Clichy
ZIP/Postal Code
92 118
Country
France
Facility Name
UH Henri Mondor
City
Créteil
ZIP/Postal Code
94 010
Country
France
Facility Name
UH Kremlin Bicêtre
City
Le Kremlin Bicêtre
ZIP/Postal Code
94 275
Country
France
Facility Name
UH Claude Huriez
City
Lille
ZIP/Postal Code
59 037
Country
France
Facility Name
Clinique Sainte Anne
City
Lyon
ZIP/Postal Code
69 003
Country
France
Facility Name
UH La Timone
City
Marseille
ZIP/Postal Code
13 385
Country
France
Facility Name
UH Marseille Nord
City
Marseille
ZIP/Postal Code
13 915
Country
France
Facility Name
H Metz-Thionville
City
Metz
ZIP/Postal Code
57 038
Country
France
Facility Name
UH Nantes
City
Nantes
ZIP/Postal Code
44 000
Country
France
Facility Name
Clinique du Trocadéro
City
Paris
ZIP/Postal Code
75 116
Country
France
Facility Name
UH Cochin
City
Paris
ZIP/Postal Code
75 679
Country
France
Facility Name
UH La Milétrie
City
Poitiers
ZIP/Postal Code
86 021
Country
France
Facility Name
UH Charles Nicolle
City
Rouen
ZIP/Postal Code
76 031
Country
France
Facility Name
UH Hôpital Civil
City
Strasbourg
ZIP/Postal Code
67 091
Country
France
Facility Name
UH Purpan
City
Toulouse
ZIP/Postal Code
31 059
Country
France
Facility Name
UH Rangueil
City
Toulouse
ZIP/Postal Code
31 059
Country
France

12. IPD Sharing Statement

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

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