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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01383746
Recruitment Status : Terminated (Not enough inclusion)
First Posted : June 28, 2011
Last Update Posted : August 7, 2013
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

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

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)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
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
Study Start Date : October 2011
Actual Primary Completion Date : August 2012
Actual Study Completion Date : October 2012

Arm Intervention/treatment
Experimental: 1
Yttrium microsphere injection
Device: Yttrium microsphere injection
Radiation therapy

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  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.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01383746

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

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Responsible Party: Assistance Publique - Hôpitaux de Paris Identifier: NCT01383746    
Other Study ID Numbers: P100701
First Posted: June 28, 2011    Key Record Dates
Last Update Posted: August 7, 2013
Last Verified: August 2013
Keywords provided by Assistance Publique - Hôpitaux de Paris:
tumor response
progression-free survival
second-line therapy
Additional relevant MeSH terms:
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Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases