Efficacy Study of Intra-hepatic Administration of Therasphere® in Association With Intravenous Chemotherapy to Treat Cholangiocarcinoma
Conditions
Cholangiocarcinoma
Conditions: official terms
Cholangiocarcinoma - Liver Neoplasms
Conditions: Keywords
Intra-hepatic Cholangiocarcinoma treatment
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Therasphere® in association with Gemcitabine and Cisplatin
Type: Radiation
Overall Status
Recruiting
Summary
The purpose of this study is to assess efficacy and tolerance of intra-hepatic administration of Yttrium 90-labelled microsphere (Theraspheres®, Nordion) in association with intravenous chemotherapy with Gemcitabin and Cisplatin for the treatment of intra-hepatic cholangiocarcinoma.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

1. Histologically confirmed intra-hepatic cholangiocarcinoma.

2. Measurable target of at least 2 cm diameter.

3. Healthy liver or cirrhosis CHILD < B8.

4. WHO-PS: 0-1.

5. Age ≥ 18 years.

6. Non-Metastatic disease in extra-hepatic (are permitted: local lymph nodes < 3 cm, less than 5 lung nodes < 11 mm).

7. Creatinine clearance (calculated with Cockcroft and Gault formula) ≥ 55 ml/min, polymorphonuclear neutrophils ≥ 1500 G/L, platelets ≥ 80 G/L, prothrombin ≥ 40% (INR ≤ 2.3), serum albumin ≥ 28 g/l, serum bilirubin ≤ 3 x LSN.

8. Pregnancy test: negative for women of childbearing potential.

9. Reliable contraception for a childbearing couple, men and woman must have an reliable contraception during the treatment and until 6 months following the end of the treatment by chemotherapy

10. Signed informed consent form.

11. Patient with national health insurance.

Exclusion Criteria:

1. Pancreas cancer or duodenum cancer invading the bile duct or ampullary cancer. Cholangiocarcinoma of the bile ducts: hilar, main duct, gallbladder.

2. Extra-hepatic metastasis (including local lymph nodes measuring > 30 mm).

3. Primary sclerosing cholangitis.

4. History of chemoembolization or radioembolization.

5. Cirrhose CHILD > B7

6. Portal vein trunk tumoral thrombosis

7. History of hepato-biliary neo adjuvant or palliative chemotherapy and/or radiotherapy.

8. Contra indication of Gemcitabine and/or Cisplatin.

9. Other invasive active cancer, excepting in situ cervical cancer and basocellular or spino cellular skin cancer treated adequately. Any history of cancer not considered as completely cured for at least one year.

10. Technical failure of the diagnostic arteriography.

11. Extra hepatic uptake on the pre-therapeutic scintigraphy not manageable with an arteriography.

12. Dosimetry study predicting lung exposure > 30 Gy.

13. Any unstable medical history (diabetes, hypertension …).

14. History of organ transplant.

15. Symptomatic grade 1 angina pectoris or grade ≥ 2 angina pectoris.

16. An evolutive neuropathy.

17. Patient who already has been involved in a clinical trial with drug intake, whether this drug was experimental or not, within 30 days before.

18. Pregnant patient or patient with breastfeeding.

19. Patient under administrative supervision.

20. Regular follow-up impossible for various reasons (psychological, familial, economical, and social).
Locations
Hôpital Beaujon - Service de Chirurgie
Clichy, France
Status: Recruiting
Contact: Olivier Farges, MD
Hôpital Henri Mondor
Créteil, France
Status: Not yet recruiting
Contact: Philippe Compagnon, MD
Hôpital saint-Eloi
Montpellier, France
Status: Not yet recruiting
Contact: Eric ASSENAT, MD
CHU Nancy - Hôpital Brabois
Nancy, France
Status: Not yet recruiting
Contact: Laurence Chone, MD
CHU- Hotel Dieu
Nantes, France
Status: Recruiting
Contact: Yann Touchefeu, MD
Centre Eugene Marquis
Rennes, France
Status: Recruiting
Contact: Eveline Boucher, MD - +33(0)299253180 - e.boucher@rennes.unicancer.fr
Start Date
September 2013
Completion Date
April 2018
Sponsors
Center Eugene Marquis
Source
Center Eugene Marquis
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page