Association of Conformational High-dose Radiotherapy and of Hyperselective Transarterial Chemoembolization in the Treatment of Hepatocellular Carcinoma
TACERTE
1 other identifier
interventional
126
1 country
18
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 hepatocellular-carcinoma
Started Jun 2011
Longer than P75 for phase_2 hepatocellular-carcinoma
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 18, 2011
CompletedFirst Posted
Study publicly available on registry
February 21, 2011
CompletedStudy Start
First participant enrolled
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 26, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 26, 2018
CompletedDecember 27, 2021
December 1, 2021
7.4 years
February 18, 2011
December 23, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Time of tumor progression radiologically (CTScan) measured by mRECIST (Modified Response Evaluation Criteria In Solid Tumor).
up to 18 months
Secondary Outcomes (6)
Evaluation of the acute toxicity at the participants
within 90 days after the treatment
Evaluation of the late toxicity at the participants
after 90 days of treatment
Evaluation of the quality of life (assessed by QLQ-EORT C30)
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 )
at week 24,week 48 and week 72
Compare the health economic implications of these regimens in these patients.
up to18 months (week 72)
- +1 more secondary outcomes
Study Arms (2)
TACE
ACTIVE COMPARATORPatients 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.
TACE + RTC
EXPERIMENTALPatients 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
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
Related Publications (1)
Feray C, Campion L, Mathurin P, Archambreaud I, Mirabel X, Bronowicki JP, Rio E, Perret C, Mineur L, Oberti F, Touchefeu Y, Gournay J, Regnault H, Edeline J, Rode A, Hillion P, Blanc JF, Khac EN, Azoulay D, Luciani A, Preglisasco AG, Faurel-Paul E, Auble H, Mornex F, Merle P. TACE and conformal radiotherapy vs. TACE alone for hepatocellular carcinoma: A randomised controlled trial. JHEP Rep. 2023 Jan 29;5(4):100689. doi: 10.1016/j.jhepr.2023.100689. eCollection 2023 Apr.
PMID: 36937990DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cyrille Feray, Pr
Henri Mondor Hospital (Paris)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2011
First Posted
February 21, 2011
Study Start
June 1, 2011
Primary Completion
October 26, 2018
Study Completion
October 26, 2018
Last Updated
December 27, 2021
Record last verified: 2021-12