Second-line Therapy of Unresectable Cholangiocarcinoma by RADIOEMBOLIZATION (CHOLANGIOSIR)
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|ClinicalTrials.gov Identifier: NCT01383746|
Recruitment Status : Terminated (Not enough inclusion)
First Posted : June 28, 2011
Last Update Posted : August 7, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Cholestasis, Progressive Familial Intrahepatic 3||Device: Yttrium microsphere injection||Phase 1 Phase 2|
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)
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy and Tolerance of RADIOEMBOLIZATION for Patients With Unresectable Intrahepatic Cholangiocarcinoma With Tumor Progression After First-line Therapy|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||October 2012|
Yttrium microsphere injection
Device: Yttrium microsphere injection
- 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 ]
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): NCT01383746
|Hôpital Saint Antoine. Service d'Hépatologie, Pole digestif.|
|Paris, France, 75012|
|Principal Investigator:||Laetitia FARTOUX, MD,||Assistance Publique - Hôpitaux de Paris|