Second-line Therapy of Unresectable Cholangiocarcinoma by RADIOEMBOLIZATION (CHOLANGIOSIR)

This study has been terminated.
(Not enough inclusion)
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris Identifier:
First received: June 27, 2011
Last updated: August 6, 2013
Last verified: August 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 Intervention Phase
Cholestasis, Progressive Familial Intrahepatic 3
Device: Yttrium microsphere injection
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Progression -free survival at 6 months (from date of inclusion) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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.

Secondary Outcome Measures:
  • Tumor response at 1 month, 2 months, 4 months, 6 months [ Time Frame: 1 month, 2 months, 4 months, 6 months ] [ Designated as safety issue: Yes ]
    Tumor response documented on imaging evaluation (MRI or CT) using RECIST criteria version 1.1.

  • Overall Survival at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Safety of RADIOEMBOLIZATION using the NCI-CTCAE V3.0 classification. [ Time Frame: 2 weeks, 1 month, 2 months, 4 months, 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 5
Study Start Date: October 2011
Study Completion Date: October 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Yttrium microsphere injection
Device: Yttrium microsphere injection
Radiation therapy
Other Name: Yttrium microsphere injection

Detailed Description:

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 :

  1. Information and signed CONSENTMENT
  2. Preparatory phase : pre-treatment mesenteric angiography and technetium-99m macroaggregated albumin scans are performed to assess gastrointestinal flow and lung shunting.
  3. 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.
  4. Follow up to J15,M1,M2,M4 and M6 : clinical examination and imaging evaluation ( scans and /or MRI)

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Unresectable intra-hepatic CCK histologically proven
  • Tumor progression documented on imaging evaluation ( CT or MRI) according to RECIST criteria version 1.1 after first-line therapy
  • Performance status < 2 ; 4) Bilirubin < 36 micromol/l
  • age > 18 years

Exclusion Criteria:

  • Extra-hepatic metastases
  • Uncontrolled biliary obstruction
  • Contra-indications to RE.
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Please refer to this study by its identifier: NCT01383746

Hôpital Saint Antoine. Service d'Hépatologie, Pole digestif.
Paris, France, 75012
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Principal Investigator: Laetitia FARTOUX, MD, Assistance Publique - Hôpitaux de Paris
  More Information


Responsible Party: Assistance Publique - Hôpitaux de Paris Identifier: NCT01383746     History of Changes
Other Study ID Numbers: P100701
Study First Received: June 27, 2011
Last Updated: August 6, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: French Data Protection Authority

Keywords provided by Assistance Publique - Hôpitaux de Paris:
tumor response
progression-free survival
second-line therapy

Additional relevant MeSH terms:
Cholestasis, Intrahepatic
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Liver Diseases
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial processed this record on October 08, 2015