Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2026-01-01 @ 5:42 PM
Study NCT ID:
NCT00540735
Status:
TERMINATED
Last Update Posted:
2010-02-04
First Post:
2007-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficiency Evaluation of Photodynamic Therapy With Photofrin® on Unresectable Type III or IV Cholangiocarcinomas
Sponsor:
University Hospital, Angers
Organization:
Study Overview
Official Title:
Efficiency Evaluation of Photodynamic Therapy With Photofrin® on Unresectable Type III or IV Cholangiocarcinomas - A Prospective, Multicentric and Randomized Study.
Status:
TERMINATED
Status Verified Date:
2007-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Big difficulties to enroll patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CK/PDT
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: