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


Phase 3
18 Years
N/A
Not Enrolling
Both
Cholangiocarcinoma

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Principal Investigator

Jean Boyer, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UH Angers

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

PHRC 2006-01

NCT ID:

NCT00540735

Start Date:

April 2008

Completion Date:

November 2009

Related Keywords:

  • Cholangiocarcinoma
  • Cholangiocarcinoma

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