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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 May 2017 by Nantes University Hospital
Information provided by (Responsible Party):
Nantes University Hospital Identifier:
First received: February 18, 2011
Last updated: May 4, 2017
Last verified: May 2017
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
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Association of Conformational High-dose Radiotherapy and of Hyperselective Transarterial Chemoembolization in the Treatment of Hepatocellular Carcinoma

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 ]

Secondary Outcome Measures:
  • Evaluation of the acute toxicity at the participants [ Time Frame: within 90 days after the treatment ]
  • Evaluation of the late toxicity at the participants [ Time Frame: 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 ]
  • 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 ]
  • Compare the health economic implications of these regimens in these patients. [ Time Frame: up to18 months (week 72) ]
  • overall survival [ Time Frame: within 3 years after first cure of TACE-DC BEADS ]

Estimated Enrollment: 174
Actual 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).

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT01300143

Contact: Cyrille Feray, Pr

CHU Amiens Recruiting
Amiens, France
Contact: Eric Nguyen Khac, MD-PhD         
Principal Investigator: Eric Nguyen Khac, Md-PhD         
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: Véronique VENDRELY, PU-PH         
Principal Investigator: Véronique VENDRELY, Pr         
AP-HP Henri Mondor Recruiting
Créteil, France
Principal Investigator: Hélène REGNAULT, MD         
CHU Dijon Recruiting
Dijon, France
Contact: Patrick HILLON, Md-PhD         
Principal Investigator: Patrick HILLON, MD-PhD         
CHD les Oudairies Recruiting
La Roche-sur-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 Recruiting
Paris, France
Contact: Jean-Didier Grange, MD         
Principal Investigator: Grange Jean-Didier, MD         
La Pitié-Salpétrière Active, not recruiting
Paris, France
CHU de Reims Recruiting
Reims, France
Principal Investigator: Alexandra HEURGUE, MD         
Centre Eugene Marquis Recruiting
Rennes, France
Principal Investigator: Julien EDELINE         
Sponsors and Collaborators
Nantes University Hospital
Principal Investigator: Cyrille Feray, Pr Henri Mondor Hospital (Paris)
  More Information

Responsible Party: Nantes University Hospital Identifier: NCT01300143     History of Changes
Other Study ID Numbers: BRD/10/06-M
Study First Received: February 18, 2011
Last Updated: May 4, 2017

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Estrogens, Non-Steroidal
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents processed this record on May 25, 2017