Second-line Therapy of Unresectable Cholangiocarcinoma by RADIOEMBOLIZATION

NCT01383746 | Terminated Phase 1 DMC

• 1 other identifier: P100701
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholestasis, Progressive Familial Intrahepatic 3

Keywords

Cholangiocarcinoma; RADIOEMBOLIZATION; tumor response; progression-free survival; safety; second-line therapy

Outcome Measures

Primary Outcomes (1)

• Progression -free survival at 6 months (from date of inclusion)

  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.

  6 months

Secondary Outcomes (3)

• Tumor response at 1 month, 2 months, 4 months, 6 months

  1 month, 2 months, 4 months, 6 months

• 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

Study Arms (1)

1

EXPERIMENTAL

Yttrium microsphere injection

Device: Yttrium microsphere injection

Interventions

Yttrium microsphere injection DEVICE

Radiation therapy

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Extra-hepatic metastases
• Uncontrolled biliary obstruction
• Contra-indications to RE.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Saint Antoine. Service d'Hépatologie, Pole digestif.

Paris, 75012, France

Location

Related Publications (9)

• 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. doi: 10.1038/sj.bjc.6603127.

  PMID: 16736026 BACKGROUND

• Khan SA, Thomas HC, Davidson BR, Taylor-Robinson SD. Cholangiocarcinoma. Lancet. 2005 Oct 8;366(9493):1303-14. doi: 10.1016/S0140-6736(05)67530-7.

  PMID: 16214602 BACKGROUND

• Patel T. Increasing incidence and mortality of primary intrahepatic cholangiocarcinoma in the United States. Hepatology. 2001 Jun;33(6):1353-7. doi: 10.1053/jhep.2001.25087.

  PMID: 11391522 BACKGROUND

• Gores GJ. Cholangiocarcinoma: current concepts and insights. Hepatology. 2003 May;37(5):961-9. doi: 10.1053/jhep.2003.50200. No abstract available.

  PMID: 12717374 BACKGROUND

• 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(Suppl 6):VI1-9. doi: 10.1136/gut.51.suppl_6.vi1. No abstract available.

  PMID: 12376491 BACKGROUND

• 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.

  PMID: 20375404 BACKGROUND

• 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. doi: 10.1016/j.ejca.2004.10.026.

  PMID: 15691639 BACKGROUND

• 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.

  PMID: 19904267 BACKGROUND

• Andre 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.

  PMID: 19238628 BACKGROUND

MeSH Terms

Conditions

Cholestasis, progressive familial intrahepatic 3; Cholangiocarcinoma

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Laetitia FARTOUX, MD,

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2011
• First Posted: June 28, 2011
• Study Start: October 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: October 1, 2012
• Last Updated: August 7, 2013

Record last verified: 2013-08

Locations

FR (1)