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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01300143
Recruitment Status : Active, not recruiting
First Posted : February 21, 2011
Last Update Posted : July 5, 2017
Information provided by (Responsible Party):
Nantes University Hospital

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).

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Other: TACE Other: TACE+ RTC Phase 2

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  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Association of Conformational High-dose Radiotherapy and of Hyperselective Transarterial Chemoembolization in the Treatment of Hepatocellular Carcinoma
Actual Study Start Date : June 2011
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : June 2020

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

Primary Outcome Measures :
  1. 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 :
  1. Evaluation of the acute toxicity at the participants [ Time Frame: within 90 days after the treatment ]
  2. Evaluation of the late toxicity at the participants [ Time Frame: after 90 days of treatment ]
  3. 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 ]
  4. 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 ]
  5. Compare the health economic implications of these regimens in these patients. [ Time Frame: up to18 months (week 72) ]
  6. overall survival [ Time Frame: within 3 years after first cure of TACE-DC BEADS ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01300143

CHU Amiens
Amiens, France
CHU d'Angers
Angers, France
CH Avignon
Avignon, France
Institut Sainte Catherine
Avignon, France
CHU de Bordeaux
Bordeaux, France
AP-HP Henri Mondor
Créteil, France
CHU Dijon
Dijon, France
CHD les Oudairies
La Roche-sur-Yon, France
CHR de Lille Hôpital Claude Huriez
Lille, France
CHU de Lyon
Lyon, France
CHU de Nancy Hôpital Brabois
Nancy, France
CHU Nantes
Nantes, France
CHR Orléans
Orléans, France
AP-HP Paul Brousse Villejuif
Paris, France
Hôpital Tenon
Paris, France
La Pitié-Salpétrière
Paris, France
CHU de Reims
Reims, France
Centre Eugene Marquis
Rennes, France
Sponsors and Collaborators
Nantes University Hospital
Principal Investigator: Cyrille Feray, Pr Henri Mondor Hospital (Paris)

Responsible Party: Nantes University Hospital Identifier: NCT01300143     History of Changes
Other Study ID Numbers: BRD/10/06-M
First Posted: February 21, 2011    Key Record Dates
Last Update Posted: July 5, 2017
Last Verified: July 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