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

This study has been terminated.
(Not enough inclusion)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01383746
First Posted: June 28, 2011
Last Update Posted: August 7, 2013
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.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
June 27, 2011
June 28, 2011
August 7, 2013
October 2011
August 2012   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01383746 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Second-line Therapy of Unresectable Cholangiocarcinoma by RADIOEMBOLIZATION
Efficacy and Tolerance of RADIOEMBOLIZATION for Patients With Unresectable Intrahepatic Cholangiocarcinoma With Tumor Progression After First-line Therapy

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.

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)
Interventional
Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Cholestasis, Progressive Familial Intrahepatic 3
Device: Yttrium microsphere injection
Radiation therapy
Experimental: 1
Yttrium microsphere injection
Intervention: Device: Yttrium microsphere injection

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
5
October 2012
August 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01383746
P100701
Yes
Not Provided
Not Provided
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Laetitia FARTOUX, MD, Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP