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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Nantes University Hospital
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01300143
First received: February 18, 2011
Last updated: April 29, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention Phase
Hepatocellular Carcinoma,
Other: TACE
Other: TACE+ RTC
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Association of Conformational High-dose Radiotherapy and of Hyperselective Transarterial Chemoembolization in the Treatment of Hepatocellular Carcinoma

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • Time to tumoral progression radiologically (CTScan) measured by mRECIST (Modified Response Evaluation Criteria In Solid Tumor). [ Time Frame: up to 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluation of the acute toxicity at the participants [ Time Frame: in 90 days follow the treatment ] [ Designated as safety issue: Yes ]
  • Evaluation of the late toxicity at the participants [ Time Frame: after 90 days of treatment ] [ Designated as safety issue: Yes ]
  • Evaluation of the quality of life (assessed by QLQ-EORT C30) [ Time Frame: the day of randomization and at 6 months ] [ Designated as safety issue: No ]
  • Evaluation of the rate of complete answers and partial answers after treatment ( by RECIST criteria ) [ Time Frame: up to 18 months ] [ Designated as safety issue: No ]
  • Compare the health economic implications of these regimens in these patients. [ Time Frame: up to18months ] [ Designated as safety issue: No ]

Estimated Enrollment: 174
Study Start Date: June 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: TACE
Patients will be treated by 2 or 3 hyperselective TACE at 0, 2 and 4 months.
Other: TACE
Control arm will be treated by 3 TACE DC beads at 0, 2 and 4 months
Experimental: RTC
Patients will be treated by one cure of TACE then, in the 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 then, two weeks later, by external conformational radiotherapy in 18 sessions

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years of age
  • ECOG 0-1
  • life expectancy ≥ 6 months
  • Hepatocellular carcinoma proven histologically or according to radiological and biochemical criteria (EASL-AASLD) in cirrhotic patients
  • Maximum lesion ≤ 9 cm
  • Non-eligible for surgery or percutaneous therapy
  • Child-Pugh A or B premature (7 points for the Child-Pugh score)
  • ASAT and ALAT < 7 x LSN
  • Technical possibility of conformational external radiotherapy
  • Technical possibility of TACE
  • All the tumoral mass must be able to be treated by TACE
  • Written consent signed by the patient

Exclusion Criteria:

  • Metastatic illness
  • Minimal lesion ≤ 5 cm
  • Viral replication B non controlled
  • 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
  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: NCT01300143

Contacts
Contact: Cyrille Feray, PHD cyrille.feray@chu-nantes.fr

Locations
France
CHU Amiens Suspended
Amiens, France
CHU d'Angers Recruiting
Angers, France
Principal Investigator: Paul CALES, PR         
CHU de Bordeaux Recruiting
Bordeaux, France
Contact: Jean Fréderic Blanc, PU-PH         
Principal Investigator: Jean Fréderic Leblanc         
AP-HP Henri Mondor Recruiting
Créteil, France
Principal Investigator: Charlotte Constantin, MD         
CHU Dijon Not yet recruiting
Dijon, France
Contact: Patrick HILLON, Md-PhD         
Principal Investigator: Patrick HILLON, MD-PhD         
CHD les Oudairies Recruiting
La Roche/Yon, France
Principal Investigator: FAROUX r FAROUX, MD         
CHR de Lille Hôpital Claude Huriez Recruiting
Lille, France
Principal Investigator: Philippe MATHURIN, Pr         
CHU de Lyon Recruiting
Lyon, France
Principal Investigator: Philippe MERLE, Pr         
Hôpital St Eloi Suspended
Montpellier, France
CHU de Nancy Hôpital Brabois Recruiting
Nancy, France
Principal Investigator: JP BRONOWICKI, Pr         
CHU Nantes Recruiting
Nantes, France
Contact: Cyrille Feray, MD PHD         
CHR Orléans Not yet recruiting
Orléans, France
Contact: Barbara Dauvois, MD         
Principal Investigator: Barbara Dauvois, MD         
Hôpital Tenon Not yet recruiting
Paris, France
Contact: Jean-Didier Grange, MD         
Principal Investigator: Grange Jean-Didier, MD         
AP-HP Paul Brousse Villejuif Not yet recruiting
Paris, France
Principal Investigator: Didier SAMUEL, Pr         
La Pitié-Salpétrière Not yet recruiting
Paris, France
Contact: Vlad RATZIU, MD-PhD         
Principal Investigator: Vlad RATZIU, MD-PhD         
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Cyrille Feray, Pr Nantes University Hospital
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01300143     History of Changes
Other Study ID Numbers: BRD 10/6-M
Study First Received: February 18, 2011
Last Updated: April 29, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Carcinoma
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on October 19, 2014