Association of Conformational High-dose Radiotherapy and of Hyperselective Transarterial Chemoembolization in the Treatment of Hepatocellular Carcinoma (TACERTE)

December 23, 2021 updated by: Nantes University Hospital
Indication : Hepatocellular carcinoma, maximum size 9 cm, with single or multiple nodes whose total tumor mass can technically be irradiated, non-resectable, and not a candidate for percutaneous therapy with recommended treatment via hyperselective transarterial chemoembolisation (TACE).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

: Phase II controlled randomized trial, multicenter, comparing the benefit of additive conformational radiotherapy after therapy with hyperselective chemoembolisation (TACE) with treatment using three TACE treatments (standard of care).

Study Type

Interventional

Enrollment (Actual)

126

Phase

  • 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
      • Amiens, France
        • CHU Amiens
      • Angers, France
        • CHU d'Angers
      • Avignon, France
        • Ch Avignon
      • Avignon, France
        • Institut Sainte Catherine
      • Bordeaux, France
        • CHU de Bordeaux
      • Créteil, France
        • AP-HP Henri Mondor
      • Dijon, France
        • CHU Dijon
      • La Roche-sur-Yon, France
        • CHD Les Oudairies
      • Lille, France
        • CHR de Lille Hôpital Claude Huriez
      • Lyon, France
        • Chu de Lyon
      • Nancy, France
        • CHU de Nancy Hôpital Brabois
      • Nantes, France
        • CHU Nantes
      • Orléans, France
        • CHR Orléans
      • Paris, France
        • La Pitié-Salpêtrière
      • Paris, France
        • Hopital Tenon
      • Paris, France
        • AP-HP Paul Brousse Villejuif
      • Reims, France
        • CHU de Reims
      • Rennes, France
        • 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

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥ 18 years of age
  • ECOG 0-1
  • life expectancy ≥ 6 months
  • Histologically proven hepatocellular carcinoma or proven according to radiological and biochemical criteria (EASL-AASLD) in cirrhotic patients
  • Maximum lesion size ≤ 9 cm
  • Non-eligible for surgery or percutaneous therapy
  • Premature Child-Pugh A or B (7 points for the Child-Pugh score)
  • AST and ALT < 7 x UNL
  • Technical possibility of conformational external radiotherapy
  • Technical possibility of TACE
  • All the tumor mass must be able to be treated by TACE
  • Written consent signed by the patient
  • Patients affiliated to a social security system

Exclusion Criteria:

  • Metastatic illness
  • Minimal lesion size ≤ 5 mm
  • Non controlled viral replication B
  • History of radiotherapy at abdominal level
  • Subjects capable of procreating without efficient contraception
  • pregnancy or nursing female patient
  • Contraindication of TACE or external conformational radiotherapy
  • Any other concomitant experimental treatment
  • Contraindication of Doxorubicin
  • Patients who are unable to respect enslaving respiratory constraints if used by sites
  • Patients who are unable to understand information and to follow protocol instructions

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: TACE
Patients will be treated by 2 or 3 cures of hyperselective TACE. The first one at week 0 and the second one at week 8. If required, a third cure of TACE could be done at week16.
Other: TACE
Control arm will be treated by 2 or 3 cures of TACE DC beads at week 0, 8 and 16 (if required)
EXPERIMENTAL: TACE + RTC
Patients will be treated by one cure of TACE at week 0. Then, patients will be treated within two weeks by external conformational radiotherapy of 54 grey fractioned in 18 sessions during 3-4 weeks.
Other: TACE+ RTC
Experimental group will be treated by one cure of TACE DC Beads at week 0 then, within two weeks, by external conformational radiotherapy in 18 sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time of tumor progression radiologically (CTScan) measured by mRECIST (Modified Response Evaluation Criteria In Solid Tumor).
Time Frame: up to 18 months
up to 18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluation of the acute toxicity at the participants
Time Frame: within 90 days after the treatment
within 90 days after the treatment
Evaluation of the late toxicity at the participants
Time Frame: after 90 days of treatment
after 90 days of treatment
Evaluation of the quality of life (assessed by QLQ-EORT C30)
Time Frame: the day of randomization (week 0), at week 12 and week 24
the day of randomization (week 0), at week 12 and week 24
Evaluation of the rate of complete, partial response and stable disease after treatment (by RECIST criteria )
Time Frame: at week 24,week 48 and week 72
at week 24,week 48 and week 72
Compare the health economic implications of these regimens in these patients.
Time Frame: up to18 months (week 72)
up to18 months (week 72)
overall survival
Time Frame: within 3 years after first cure of TACE-DC BEADS
within 3 years after first cure of TACE-DC BEADS

Collaborators and Investigators

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

Sponsor

Nantes University Hospital

Investigators

  • Principal Investigator: Cyrille Feray, Pr, Henri Mondor Hospital (Paris)

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)

June 1, 2011

Primary Completion (ACTUAL)

October 26, 2018

Study Completion (ACTUAL)

October 26, 2018

Study Registration Dates

First Submitted

February 18, 2011

First Submitted That Met QC Criteria

February 18, 2011

First Posted (ESTIMATE)

February 21, 2011

Study Record Updates

Last Update Posted (ACTUAL)

December 27, 2021

Last Update Submitted That Met QC Criteria

December 23, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRD/10/06-M

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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