Efficiency Evaluation of Photodynamic Therapy With Photofrin® on Unresectable Type III or IV Cholangiocarcinomas (CK/PDT)
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|ClinicalTrials.gov Identifier: NCT00540735|
Recruitment Status : Terminated (Big difficulties to enroll patients)
First Posted : October 8, 2007
Last Update Posted : February 4, 2010
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 or disease||Intervention/treatment||Phase|
|Cholangiocarcinoma||Procedure: photodynamic therapy||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficiency Evaluation of Photodynamic Therapy With Photofrin® on Unresectable Type III or IV Cholangiocarcinomas - A Prospective, Multicentric and Randomized Study.|
|Study Start Date :||April 2008|
|Estimated Study Completion Date :||November 2009|
|Procedure: photodynamic therapy|
|No Intervention: 2|
- Patients' survival compared between both groups : PDT and non-PDT.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00540735
|Amiens, France, 80 000|
|Angers, France, 49933|
|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 La Timone|
|Marseille, France, 13 385|
|UH Marseille Nord|
|Marseille, France, 13 915|
|Metz, France, 57 038|
|Nantes, France, 44 000|
|Clinique du Trocadéro|
|Paris, France, 75 116|
|Paris, France, 75 679|
|UH La Milétrie|
|Poitiers, France, 86 021|
|UH Charles Nicolle|
|Rouen, France, 76 031|
|UH Hôpital Civil|
|Strasbourg, France, 67 091|
|Toulouse, France, 31 059|
|Toulouse, France, 31 059|
|Principal Investigator:||Jean Boyer, MD, PhD||UH Angers|