Clinical trial NCT01912053: Efficacy Study of Intra-hepatic Administration of Therasphere® in Association With Intravenous Chemotherapy to Treat Cholangiocarcinoma
Official title: An Open-label, Multicenter, Phase II Trial, to Evaluate the Efficacy of Intra-hepatic Administration of Yttrium 90-labelled Microspheres (Therasphere®, Nordion) in Association With Intravenous Chemotherapy With Gemcitabine and Cisplatin for the Treatment of Intra-hepatic Cholangiocarcinoma, First Line.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cholangiocarcinoma
Keywords: Intra-hepatic Cholangiocarcinoma treatment
Lead sponsor: Center Eugene Marquis
Sponsor class: OTHER
First posted: 2013-07-30
Enrollment: 41
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: 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.


Eligibility 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).

Primary outcomes:
measure: Radiological response rate to the treatment with the association of chemotherapy and radioembolization
timeFrame: 3 months after radioembolization
Secondary outcomes:
measure: Tolerance of intra-hepatic administration of Yttrium 90-labelled microspheres in association with intravenous chemotherapy with Gemcitabine and Cisplatin assessed according NCI/CTC AE version 4.
timeFrame: Up to 24 months
measure: Tumor markers changes (CA19.9, CEA and AFP)
timeFrame: Up to 24 months
measure: Radiological response rate by the CHOI criteria
timeFrame: Up to 24 months
measure: Change in metabolic activity measured by TEP
timeFrame: Change from baseline in metabolic activity 15 and 24 weeks after last treatment by microspheres
measure: Changes of liver volume
timeFrame: Up to 24 months
measure: Tumoral and non-tumoral dosimetric assessment of the liver
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Clichy
country: France
facility: Hôpital Beaujon - Service de Chirurgie
city: Créteil
country: France
facility: Hôpital Henri Mondor
city: Montpellier
country: France
facility: Hôpital saint-Eloi
city: Nancy
country: France
facility: CHU Nancy - Hôpital Brabois
city: Nantes
country: France
facility: CHU- Hotel Dieu
city: Poitiers
country: France
facility: CHU Poitiers
city: Rennes
country: France
facility: Centre Eugene Marquis
Study officials:
affiliation: Centre Eugene Marquis
name: Eveline Boucher, MD
role: PRINCIPAL_INVESTIGATOR
References: