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

NCT01912053 | Completed Phase 2 DMC

• 3 other identifiers: 2012-EB-CHOL-Th2012-001213-16A121007-71
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 7

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.

Conditions

Cholangiocarcinoma

Keywords

Intra-hepatic Cholangiocarcinoma treatment

Outcome Measures

Primary Outcomes (1)

• Radiological response rate to the treatment with the association of chemotherapy and radioembolization

  Evaluation according RECIST 1.1 criteria. Rate will be reassessed every 8 weeks

  3 months after radioembolization

Secondary Outcomes (6)

• 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

• Tumor markers changes (CA19.9, CEA and AFP)

  Up to 24 months

• Radiological response rate by the CHOI criteria

  Up to 24 months

• 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

Study Arms (1)

Therasphere®

EXPERIMENTAL

Therasphere® in association with Gemcitabine and Cisplatin

Radiation: Therasphere® in association with Gemcitabine and Cisplatin

Interventions

Therasphere® in association with Gemcitabine and Cisplatin RADIATION

Therasphere® is a radioelement

Also known as: 90-Yttrium theraspheres

Therasphere®

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed intra-hepatic cholangiocarcinoma.
• Measurable target of at least 2 cm diameter.
• Healthy liver or cirrhosis CHILD \< B8.
• WHO-PS: 0-1.
• Age ≥ 18 years.
• Non-Metastatic disease in extra-hepatic (are permitted: local lymph nodes \< 3 cm, less than 5 lung nodes \< 11 mm).
• 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.
• Pregnancy test: negative for women of childbearing potential.
• 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
• Signed informed consent form.
• Patient with national health insurance.

You may not qualify if:

• Pancreas cancer or duodenum cancer invading the bile duct or ampullary cancer. Cholangiocarcinoma of the bile ducts: hilar, main duct, gallbladder.
• Extra-hepatic metastasis (including local lymph nodes measuring \> 30 mm).
• Primary sclerosing cholangitis.
• History of chemoembolization or radioembolization.
• Cirrhose CHILD \> B7
• Portal vein trunk tumoral thrombosis
• History of hepato-biliary neo adjuvant or palliative chemotherapy and/or radiotherapy.
• Contra indication of Gemcitabine and/or Cisplatin.
• 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.
• Technical failure of the diagnostic arteriography.
• Extra hepatic uptake on the pre-therapeutic scintigraphy not manageable with an arteriography.
• Dosimetry study predicting lung exposure \> 30 Gy.
• Any unstable medical history (diabetes, hypertension …).
• History of organ transplant.
• Symptomatic grade 1 angina pectoris or grade ≥ 2 angina pectoris.

Sponsors & Collaborators

• Center Eugene Marquis: lead

Study Sites (7)

Hôpital Beaujon - Service de Chirurgie

Clichy, 92118, France

Location

Hôpital Henri Mondor

Créteil, 94010, France

Location

Hôpital saint-Eloi

Montpellier, 34295, France

Location

CHU Nancy - Hôpital Brabois

Nancy, 54000, France

Location

CHU- Hotel Dieu

Nantes, 44093, France

Location

CHU Poitiers

Poitiers, France

Location

Centre Eugene Marquis

Rennes, 35042, France

Location

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

Association; Gemcitabine; Cisplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Psychotherapeutic Processes; Psychotherapy; Behavioral Disciplines and Activities; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Eveline Boucher, MD

  Centre Eugene Marquis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2013
• First Posted: July 30, 2013
• Study Start: September 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: November 1, 2017
• Last Updated: May 11, 2018

Record last verified: 2018-01

Locations

FR (7)