Second-line Therapy of Unresectable Cholangiocarcinoma by RADIOEMBOLIZATION (CHOLANGIOSIR)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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.
- 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 ]
| Estimated Enrollment: | 25 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | June 2014 (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 :
- Information and signed CONSENTMENT
- Preparatory phase : pre-treatment mesenteric angiography and technetium-99m macroaggregated albumin scans are performed to assess gastrointestinal flow and lung shunting.
- 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.
- 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 |
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| Contact: Laetitia FARTOUX, MD | + 33 (0) 49 28 23 82 | laetitia.fartoux@sat.aphp.fr |
| France | |
| Hôpital Saint Antoine. Service d'Hépatologie, Pole digestif. | Recruiting |
| Paris, France, 75012 | |
| Contact: Laetitia FARTOUX, MD + 33 (0) 49 28 23 82 laetitia.fartoux@sat.aphp.fr | |
| Principal Investigator: Laetitia Fartoux, MD | |
| 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: | December 10, 2012 |
| 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 Bile Duct Diseases Biliary Tract Diseases Digestive System Diseases |
Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Liver Diseases |
ClinicalTrials.gov processed this record on June 17, 2013