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: May 22, 2015
Last verified: April 2014
  Purpose

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).


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 of tumor 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: within 90 days after 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 (week 0), at week 12 and week 24 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Compare the health economic implications of these regimens in these patients. [ Time Frame: up to18 months (week 72) ] [ Designated as safety issue: No ]
  • overall survival [ Time Frame: within 3 years after first cure of TACE-DC BEADS ] [ Designated as safety issue: No ]

Estimated Enrollment: 174
Study Start Date: June 2011
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  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
  • 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
  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, Pr cyrille.feray@hmn.aphp.fr

Locations
France
CHU Amiens Active, not recruiting
Amiens, France
CHU d'Angers Recruiting
Angers, France
Principal Investigator: Paul CALES, PR         
CH Avignon Recruiting
Avignon, France
Principal Investigator: Jean-Pierre ARPURT, MD         
Institut Sainte Catherine Recruiting
Avignon, France
Principal Investigator: Laurent MINEUR, MD         
CHU de Bordeaux Recruiting
Bordeaux, France
Contact: Jean Fréderic Blanc, PU-PH         
Principal Investigator: Jean Fréderic BLANC, Pr         
AP-HP Henri Mondor Recruiting
Créteil, France
Principal Investigator: Charlotte Costentin, MD         
CHU Dijon Recruiting
Dijon, France
Contact: Patrick HILLON, Md-PhD         
Principal Investigator: Patrick HILLON, MD-PhD         
CHD les Oudairies Recruiting
La Roche/Yon, France
Principal Investigator: Roger 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 Withdrawn
Montpellier, France
CHU de Nancy Hôpital Brabois Recruiting
Nancy, France
Principal Investigator: JP BRONOWICKI, Pr         
CHU Nantes Recruiting
Nantes, France
Principal Investigator: Cyrille Feray, Pr         
CHR Orléans Active, not recruiting
Orléans, France
AP-HP Paul Brousse Villejuif Recruiting
Paris, France
Principal Investigator: Didier SAMUEL, Pr         
Hôpital Tenon Active, not recruiting
Paris, France
La Pitié-Salpétrière Active, not recruiting
Paris, France
CHU de Reims Not yet recruiting
Reims, France
Principal Investigator: Alexandra HEURGUE, MD         
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Cyrille Feray, Pr Henri Mondor Hospital (Paris)
  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: May 22, 2015
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on July 27, 2015