CHOLANGIOSIR: Second-line Therapy of Unresectable Cholangiocarcinoma by RADIOEMBOLIZATION
Study Details
Study Description
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 |
|---|---|---|
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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 :
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Information and signed CONSENTMENT
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Preparatory phase : pre-treatment mesenteric angiography and technetium-99m macroaggregated albumin scans are performed to assess gastrointestinal flow and lung shunting.
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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.
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Follow up to J15,M1,M2,M4 and M6 : clinical examination and imaging evaluation ( scans and /or MRI)
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 Yttrium microsphere injection |
Device: Yttrium microsphere injection
Radiation therapy
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Outcome Measures
Primary Outcome Measures
- Progression -free survival at 6 months (from date of inclusion) [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
- Tumor response at 1 month, 2 months, 4 months, 6 months [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 [6 months]
- Safety of RADIOEMBOLIZATION using the NCI-CTCAE V3.0 classification. [2 weeks, 1 month, 2 months, 4 months, 6 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Unresectable intra-hepatic CCK histologically proven
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Tumor progression documented on imaging evaluation ( CT or MRI) according to RECIST criteria version 1.1 after first-line therapy
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Performance status < 2 ; 4) Bilirubin < 36 micromol/l
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age > 18 years
Exclusion Criteria:
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Extra-hepatic metastases
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Uncontrolled biliary obstruction
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Contra-indications to RE.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
- André T, Reyes-Vidal JM, Fartoux L, Ross P, Leslie M, Rosmorduc O, Clemens MR, Louvet C, Perez N, Mehmud F, Scheithauer W. Gemcitabine and oxaliplatin in advanced biliary tract carcinoma: a phase II study. Br J Cancer. 2008 Sep 16;99(6):862-7. doi: 10.1038/sj.bjc.6604628.
- Ducreux M, Van Cutsem E, Van Laethem JL, Gress TM, Jeziorski K, Rougier P, Wagener T, Anak O, Baron B, Nordlinger B; EORTC Gastro Intestinal Tract Cancer Group. A randomised phase II trial of weekly high-dose 5-fluorouracil with and without folinic acid and cisplatin in patients with advanced biliary tract carcinoma: results of the 40955 EORTC trial. Eur J Cancer. 2005 Feb;41(3):398-403.
- Gores GJ. Cholangiocarcinoma: current concepts and insights. Hepatology. 2003 May;37(5):961-9. Review.
- Khan SA, Davidson BR, Goldin R, Pereira SP, Rosenberg WM, Taylor-Robinson SD, Thillainayagam AV, Thomas HC, Thursz MR, Wasan H; British Society of Gastroenterology. Guidelines for the diagnosis and treatment of cholangiocarcinoma: consensus document. Gut. 2002 Nov;51 Suppl 6:VI1-9.
- Khan SA, Thomas HC, Davidson BR, Taylor-Robinson SD. Cholangiocarcinoma. Lancet. 2005 Oct 8;366(9493):1303-14. Review. Erratum in: Lancet. 2006 May 20;367(9523):1656.
- Patel T. Increasing incidence and mortality of primary intrahepatic cholangiocarcinoma in the United States. Hepatology. 2001 Jun;33(6):1353-7.
- Valle J, Wasan H, Palmer DH, Cunningham D, Anthoney A, Maraveyas A, Madhusudan S, Iveson T, Hughes S, Pereira SP, Roughton M, Bridgewater J; ABC-02 Trial Investigators. Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. N Engl J Med. 2010 Apr 8;362(14):1273-81. doi: 10.1056/NEJMoa0908721.
- Wagner AD, Buechner-Steudel P, Moehler M, Schmalenberg H, Behrens R, Fahlke J, Wein A, Behl S, Kuss O, Kleber G, Fleig WE. Gemcitabine, oxaliplatin and 5-FU in advanced bile duct and gallbladder carcinoma: two parallel, multicentre phase-II trials. Br J Cancer. 2009 Dec 1;101(11):1846-52. doi: 10.1038/sj.bjc.6605377. Epub 2009 Nov 10.
- West J, Wood H, Logan RF, Quinn M, Aithal GP. Trends in the incidence of primary liver and biliary tract cancers in England and Wales 1971-2001. Br J Cancer. 2006 Jun 5;94(11):1751-8.
- P100701