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

May 7, 2018 updated by: Center Eugene Marquis

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
41

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clichy, France, 92118
        • Hôpital Beaujon - Service de Chirurgie
      • Créteil, France, 94010
        • Hopital Henri Mondor
      • Montpellier, France, 34295
        • Hôpital Saint-Eloi
      • Nancy, France, 54000
        • CHU Nancy - Hôpital Brabois
      • Nantes, France, 44093
        • CHU- Hotel Dieu
      • Poitiers, France
        • CHU Poitiers
      • Rennes, France, 35042
        • Centre Eugene Marquis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Therasphere®
Therasphere® in association with Gemcitabine and Cisplatin
Radiation: Therasphere® in association with Gemcitabine and Cisplatin
Therasphere® is a radioelement
Other Names:
  • 90-Yttrium theraspheres

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Radiological response rate to the treatment with the association of chemotherapy and radioembolization
Time Frame: 3 months after radioembolization
Evaluation according RECIST 1.1 criteria. Rate will be reassessed every 8 weeks
3 months after radioembolization

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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
Up to 24 months
Tumor markers changes (CA19.9, CEA and AFP)
Time Frame: Up to 24 months
Markers will be analysed every 8 weeks during treatment period and if applicable every 12 weeks after surgery
Up to 24 months
Radiological response rate by the CHOI criteria
Time Frame: Up to 24 months
every 8 weeks and every 12 weeks after surgery if applicable
Up to 24 months
Change in metabolic activity measured by TEP
Time Frame: Change from baseline in metabolic activity 15 and 24 weeks after last treatment by microspheres
Change from baseline in metabolic activity 15 and 24 weeks after last treatment by microspheres
Changes of liver volume
Time Frame: Up to 24 months
Every 8 weeks during treatment and every 12 weeks after surgery if applicable
Up to 24 months
Tumoral and non-tumoral dosimetric assessment of the liver
Time Frame: Up to 6 months
Data obtained from SPECT/CT performed at each hepatic scintigraphy
Up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Center Eugene Marquis

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Eveline Boucher, MD, Centre Eugene Marquis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 17, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 30, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2012-EB-CHOL-Th
  • 2012-001213-16 (EudraCT Number)
  • A121007-71 (Registry Identifier: French National Health)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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