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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2017-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Cholangiocarcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Therasphere®

Therasphere® in association with Gemcitabine and Cisplatin

Group Type EXPERIMENTAL

Therasphere® in association with Gemcitabine and Cisplatin

Intervention Type RADIATION

Therasphere® is a radioelement

Interventions

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Therasphere® in association with Gemcitabine and Cisplatin

Therasphere® is a radioelement

Intervention Type RADIATION

Other Intervention Names

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90-Yttrium theraspheres

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No