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

This study has been terminated.
(Not enough inclusion)
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01383746
First received: June 27, 2011
Last updated: August 6, 2013
Last verified: August 2013
  Purpose

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)
  Eligibility

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01383746

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

Publications:

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov 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:
Cholangiocarcinoma
RADIOEMBOLIZATION
tumor response
progression-free survival
safety
second-line therapy

Additional relevant MeSH terms:
Cholangiocarcinoma
Cholestasis
Cholestasis, Intrahepatic
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on October 02, 2014