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

NCT00540735 | Terminated Phase 3 DMC

• 1 other identifier: PHRC 2006-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 18

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.

Conditions

Cholangiocarcinoma

Outcome Measures

Primary Outcomes (1)

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

Study Arms (2)

1

EXPERIMENTAL

PDT

Procedure: photodynamic therapy

2

NO INTERVENTION

Interventions

photodynamic therapy PROCEDURE

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Pregnant, parturient or breastfeeding women.
• Non menopaused woman without an efficient contraception.
• Patient under 18.

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (18)

UH Amiens

Amiens, 80 000, France

Location

UH Angers

Angers, 49933, France

Location

H Beaujon

Clichy, 92 118, France

Location

UH Henri Mondor

Créteil, 94 010, France

Location

UH Kremlin Bicêtre

Le Kremlin-Bicêtre, 94 275, France

Location

UH Claude Huriez

Lille, 59 037, France

Location

Clinique Sainte Anne

Lyon, 69 003, France

Location

UH La Timone

Marseille, 13 385, France

Location

UH Marseille Nord

Marseille, 13 915, France

Location

H Metz-Thionville

Metz, 57 038, France

Location

UH Nantes

Nantes, 44 000, France

Location

Clinique du Trocadéro

Paris, 75 116, France

Location

UH Cochin

Paris, 75 679, France

Location

UH La Milétrie

Poitiers, 86 021, France

Location

UH Charles Nicolle

Rouen, 76 031, France

Location

UH Hôpital Civil

Strasbourg, 67 091, France

Location

UH Purpan

Toulouse, 31 059, France

Location

UH Rangueil

Toulouse, 31 059, France

Location

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

Photochemotherapy

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy

Study Officials

• Jean Boyer, MD, PhD

  UH Angers

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: October 5, 2007
• First Posted: October 8, 2007
• Study Start: April 1, 2008
• Study Completion: November 1, 2009
• Last Updated: February 4, 2010

Record last verified: 2007-10

Locations

FR (18)