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

Primary Purpose

Hepatocellular Carcinoma

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
TACE
TACE+ RTC
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Amiens
  • CHU d'Angers
  • CH Avignon
  • Institut Sainte Catherine
  • CHU de Bordeaux
  • AP-HP Henri Mondor
  • CHU Dijon
  • CHD les Oudairies
  • CHR de Lille Hôpital Claude Huriez
  • CHU de Lyon
  • CHU de Nancy Hôpital Brabois
  • CHU Nantes
  • CHR Orléans
  • AP-HP Paul Brousse Villejuif
  • Hôpital Tenon
  • La Pitié-Salpétrière
  • CHU de Reims
  • Centre Eugene Marquis

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

TACE

TACE + RTC

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Time of tumor progression radiologically (CTScan) measured by mRECIST (Modified Response Evaluation Criteria In Solid Tumor).

Secondary Outcome Measures

Evaluation of the acute toxicity at the participants
Evaluation of the late toxicity at the participants
Evaluation of the quality of life (assessed by QLQ-EORT C30)
Evaluation of the rate of complete, partial response and stable disease after treatment (by RECIST criteria )
Compare the health economic implications of these regimens in these patients.
overall survival

Full Information

First Posted
February 18, 2011
Last Updated
December 23, 2021
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01300143
Brief Title
Association of Conformational High-dose Radiotherapy and of Hyperselective Transarterial Chemoembolization in the Treatment of Hepatocellular Carcinoma
Acronym
TACERTE
Official Title
Association of Conformational High-dose Radiotherapy and of Hyperselective Transarterial Chemoembolization in the Treatment of Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
June 2011 (Actual)
Primary Completion Date
October 26, 2018 (Actual)
Study Completion Date
October 26, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TACE
Arm Type
Active Comparator
Arm Description
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.
Arm Title
TACE + RTC
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
TACE
Intervention Description
Control arm will be treated by 2 or 3 cures of TACE DC beads at week 0, 8 and 16 (if required)
Intervention Type
Other
Intervention Name(s)
TACE+ RTC
Intervention Description
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
Primary Outcome Measure Information:
Title
Time of tumor progression radiologically (CTScan) measured by mRECIST (Modified Response Evaluation Criteria In Solid Tumor).
Time Frame
up to 18 months
Secondary Outcome Measure Information:
Title
Evaluation of the acute toxicity at the participants
Time Frame
within 90 days after the treatment
Title
Evaluation of the late toxicity at the participants
Time Frame
after 90 days of treatment
Title
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
Title
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
Title
Compare the health economic implications of these regimens in these patients.
Time Frame
up to18 months (week 72)
Title
overall survival
Time Frame
within 3 years after first cure of TACE-DC BEADS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cyrille Feray, Pr
Organizational Affiliation
Henri Mondor Hospital (Paris)
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Amiens
City
Amiens
Country
France
Facility Name
CHU d'Angers
City
Angers
Country
France
Facility Name
CH Avignon
City
Avignon
Country
France
Facility Name
Institut Sainte Catherine
City
Avignon
Country
France
Facility Name
CHU de Bordeaux
City
Bordeaux
Country
France
Facility Name
AP-HP Henri Mondor
City
Créteil
Country
France
Facility Name
CHU Dijon
City
Dijon
Country
France
Facility Name
CHD les Oudairies
City
La Roche-sur-Yon
Country
France
Facility Name
CHR de Lille Hôpital Claude Huriez
City
Lille
Country
France
Facility Name
CHU de Lyon
City
Lyon
Country
France
Facility Name
CHU de Nancy Hôpital Brabois
City
Nancy
Country
France
Facility Name
CHU Nantes
City
Nantes
Country
France
Facility Name
CHR Orléans
City
Orléans
Country
France
Facility Name
AP-HP Paul Brousse Villejuif
City
Paris
Country
France
Facility Name
Hôpital Tenon
City
Paris
Country
France
Facility Name
La Pitié-Salpétrière
City
Paris
Country
France
Facility Name
CHU de Reims
City
Reims
Country
France
Facility Name
Centre Eugene Marquis
City
Rennes
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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