Efficacy Study of Intra-hepatic Administration of Therasphere® in Association With Intravenous Chemotherapy to Treat Cholangiocarcinoma

Phase 2

Completed

• Conditions: Cholangiocarcinoma
• Interventions: Radiation: Therasphere® in association with Gemcitabine and Cisplatin

• Registration Number: NCT01912053
• Lead Sponsor: Center Eugene Marquis

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-07-17
• Study First Submitted QC: 2013-07-29
• Study First Posted: 2013-07-30
• Study Start: 2013-09
• Primary Completion: 2016-12
• Study Completion: 2017-11
• Status Verified: 2018-01
• Last Update Submitted: 2018-05-07
• Last Update Posted: 2018-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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.

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Therasphere®	Therasphere® in association with Gemcitabine and Cisplatin	Therasphere® in association with Gemcitabine and Cisplatin

Primary Outcome Measures

Name	Time	Method
Radiological response rate to the treatment with the association of chemotherapy and radioembolization	3 months after radioembolization	Evaluation according RECIST 1.1 criteria. Rate will be reassessed every 8 weeks

Secondary Outcome Measures

Name	Time	Method
Change in metabolic activity measured by TEP	Change from baseline in metabolic activity 15 and 24 weeks after last treatment by microspheres
Changes of liver volume	Up to 24 months	Every 8 weeks during treatment and every 12 weeks after surgery if applicable
Tumoral and non-tumoral dosimetric assessment of the liver	Up to 6 months	Data obtained from SPECT/CT performed at each hepatic scintigraphy
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.	Up to 24 months	Grade 3-4 toxicity appearance.Time between 1st treatment administration and date of 1st appearance of a grade 3-4 toxicity or date of last toxicities assessment in case no grade 3-4 toxicity
Tumor markers changes (CA19.9, CEA and AFP)	Up to 24 months	Markers will be analysed every 8 weeks during treatment period and if applicable every 12 weeks after surgery
Radiological response rate by the CHOI criteria	Up to 24 months	every 8 weeks and every 12 weeks after surgery if applicable

Trial Locations

Locations (7)

Hôpital saint-Eloi; 🇫🇷 Montpellier, France

Hôpital Henri Mondor; 🇫🇷 Créteil, France

CHU- Hotel Dieu; 🇫🇷 Nantes, France

Hôpital Beaujon - Service de Chirurgie; 🇫🇷 Clichy, France

CHU Poitiers; 🇫🇷 Poitiers, France

Centre Eugene Marquis; 🇫🇷 Rennes, France

CHU Nancy - Hôpital Brabois; 🇫🇷 Nancy, France