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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Center Eugene Marquis
Sponsor:
Information provided by (Responsible Party):
Center Eugene Marquis
ClinicalTrials.gov Identifier:
NCT01912053
First received: July 17, 2013
Last updated: January 20, 2014
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Cholangiocarcinoma
Radiation: Therasphere® in association with Gemcitabine and Cisplatin
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Center Eugene Marquis:

Primary Outcome Measures:
  • Radiological response rate to the treatment with the association of chemotherapy and radioembolization [ Time Frame: 3 months after radioembolization ] [ Designated as safety issue: No ]
    Evaluation according RECIST 1.1 criteria. Rate will be reassessed every 8 weeks


Secondary Outcome Measures:
  • 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. [ Time Frame: Up to 24 months ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
    every 8 weeks and every 12 weeks after surgery if applicable

  • Change in metabolic activity measured by TEP [ Time Frame: Change from baseline in metabolic activity 15 and 24 weeks after last treatment by microspheres ] [ Designated as safety issue: No ]
  • Changes of liver volume [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
    Every 8 weeks during treatment and every 12 weeks after surgery if applicable

  • Tumoral and non-tumoral dosimetric assessment of the liver [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
    Data obtained from SPECT/CT performed at each hepatic scintigraphy


Estimated Enrollment: 41
Study Start Date: September 2013
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Therasphere®
Therasphere® in association with Gemcitabine and Cisplatin
Radiation: Therasphere® in association with Gemcitabine and Cisplatin
Therasphere® is a radioelement
Other Name: 90-Yttrium theraspheres

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01912053

Contacts
Contact: Eveline Boucher, MD +33(0)299253180 e.boucher@rennes.unicancer.fr

Locations
France
Hôpital Beaujon - Service de Chirurgie Not yet recruiting
Clichy, France, 92118
Contact: Olivier Frages, MD         
Principal Investigator: Olivier Farges, MD         
Hôpital Henri Mondor Not yet recruiting
Créteil, France, 94010
Contact: Philippe Compagnon, MD         
Principal Investigator: Philippe Compagnon, MD         
Hôpital saint-Eloi Not yet recruiting
Montpellier, France, 34295
Contact: Eric ASSENAT, MD         
Principal Investigator: Eric ASSENAT, MD         
CHU Nancy - Hôpital Brabois Not yet recruiting
Nancy, France, 54000
Contact: Laurence Chone, MD         
Principal Investigator: Laurence Chone, MD         
CHU- Hotel Dieu Recruiting
Nantes, France, 44093
Contact: Françoise Kreaber-Brodere, MD         
Principal Investigator: Yann Touchefeu, MD         
Centre Eugene Marquis Recruiting
Rennes, France, 35042
Contact: Eveline Boucher, MD    +33(0)299253180    e.boucher@rennes.unicancer.fr   
Principal Investigator: Eveline Boucher, MD         
Institut Gustave Roussy - Unité de Gastro-Entérologie Not yet recruiting
Villejuif, France, 94805
Contact: David Malka, MD         
Principal Investigator: David Malka, MD         
Sponsors and Collaborators
Center Eugene Marquis
Investigators
Principal Investigator: Eveline Boucher, MD Centre Eugene Marquis
  More Information

No publications provided

Responsible Party: Center Eugene Marquis
ClinicalTrials.gov Identifier: NCT01912053     History of Changes
Other Study ID Numbers: 2012-EB-CHOL-Th, 2012-001213-16, A121007-71
Study First Received: July 17, 2013
Last Updated: January 20, 2014
Health Authority: France : ANSM (Agence Nationale de Sécurité du Médicament et des Produits de Santé)

Keywords provided by Center Eugene Marquis:
Intra-hepatic Cholangiocarcinoma treatment

Additional relevant MeSH terms:
Cholangiocarcinoma
Liver Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Gemcitabine
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014