Clinical trial NCT01383746: Second-line Therapy of Unresectable Cholangiocarcinoma by RADIOEMBOLIZATION
Official title: Efficacy and Tolerance of RADIOEMBOLIZATION for Patients With Unresectable Intrahepatic Cholangiocarcinoma With Tumor Progression After First-line Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Cholestasis, Progressive Familial Intrahepatic 3
Keywords: Cholangiocarcinoma
RADIOEMBOLIZATION
tumor response
progression-free survival
safety
second-line therapy
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2011-06-28
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Progression -free survival at 6 months (from date of inclusion)
timeFrame: 6 months
Secondary outcomes:
measure: Tumor response at 1 month, 2 months, 4 months, 6 months
timeFrame: 1 month, 2 months, 4 months, 6 months
measure: Overall Survival at 6 months
timeFrame: 6 months
measure: Safety of RADIOEMBOLIZATION using the NCI-CTCAE V3.0 classification.
timeFrame: 2 weeks, 1 month, 2 months, 4 months, 6 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Saint Antoine. Service d'Hépatologie, Pole digestif.
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Laetitia FARTOUX, MD,
role: PRINCIPAL_INVESTIGATOR
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