Second-line Therapy of Unresectable Cholangiocarcinoma by RADIOEMBOLIZATION (CHOLANGIOSIR)
Cholangiocarcinoma (CCK) is a rare tumor (2000 new cases/year in France) with very poor prognosis (overall survival < 3% at 5 years). Less than 20% of patients may benefit from curative surgical resection and most patients have medical treatment by palliative treatment by palliative chemotherapy. It is not standard first-line chemotherapy validated for unresectable CCK, but the best objective response rate (OR) and overall survival (OS) are observed with gemcitabine and platinum associations (OR 24 to 36% and OS between 9.5 to 15.4 months). In case of tumor progression ater this first line therapy, no treatment is currently being validated.
RADIOEMBOLIZATION (RE) is a new, transarterial approach to radiation therapy using 90 Yttrium microspheres.
In the patients with unresectable CCK , the first pilot studies showed interesting results with rates of OR 45 to 90% and a median OS of 14.9 mots and an acceptable safety.
Study Hypothesis : RE could help achieve tumor stabilization in patients with intra-hepatic CCK in tumor progression after first-line therapy.
|Cholestasis, Progressive Familial Intrahepatic 3||Device: Yttrium microsphere injection||Phase 1 Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Efficacy and Tolerance of RADIOEMBOLIZATION for Patients With Unresectable Intrahepatic Cholangiocarcinoma With Tumor Progression After First-line Therapy|
- Progression -free survival at 6 months (from date of inclusion) [ Time Frame: 6 months ]Progression -free survival defined by the number of patients alive at 6 months without tumor progression documented on imaging evaluation ( MRI or CT) using RECIST criteria version 1.1.
- Tumor response at 1 month, 2 months, 4 months, 6 months [ Time Frame: 1 month, 2 months, 4 months, 6 months ]Tumor response documented on imaging evaluation (MRI or CT) using RECIST criteria version 1.1.
- Overall Survival at 6 months [ Time Frame: 6 months ]
- Safety of RADIOEMBOLIZATION using the NCI-CTCAE V3.0 classification. [ Time Frame: 2 weeks, 1 month, 2 months, 4 months, 6 months ]
|Study Start Date:||October 2011|
|Study Completion Date:||October 2012|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
Yttrium microsphere injection
Device: Yttrium microsphere injection
Extended description of the protocol, including information not already contained in other fields, such as comparison studied.
It is a pilot study including 20 patients with unresectable intra-hepatic CCK in tumor progression after first-line therapy.
Description of the protocol :
- Information and signed CONSENTMENT
- Preparatory phase : pre-treatment mesenteric angiography and technetium-99m macroaggregated albumin scans are performed to assess gastrointestinal flow and lung shunting.
- Therapeutic phase : intra-arterial administration of resin-based microspheres ( SIRSPHERES, SIRTEX). The RE can be performed in 2 sessions, especially if liver disease is bi-lobar.
- Follow up to J15,M1,M2,M4 and M6 : clinical examination and imaging evaluation ( scans and /or MRI)
Please refer to this study by its ClinicalTrials.gov identifier: NCT01383746
|Hôpital Saint Antoine. Service d'Hépatologie, Pole digestif.|
|Paris, France, 75012|
|Principal Investigator:||Laetitia FARTOUX, MD,||Assistance Publique - Hôpitaux de Paris|