Association of Conformational High-dose Radiotherapy and of Hyperselective Transarterial Chemoembolization in the Treatment of Hepatocellular Carcinoma
NCT ID: NCT01300143
Last Updated: 2021-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
126 participants
INTERVENTIONAL
2011-06-30
2018-10-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
TACE
Control arm will be treated by 2 or 3 cures of TACE DC beads at week 0, 8 and 16 (if required)
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.
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
Interventions
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TACE
Control arm will be treated by 2 or 3 cures of TACE DC beads at week 0, 8 and 16 (if required)
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Nantes University Hospital
OTHER
Responsible Party
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Principal Investigators
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Cyrille Feray, Pr
Role: PRINCIPAL_INVESTIGATOR
Henri Mondor Hospital (Paris)
Locations
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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
Countries
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References
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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.
Other Identifiers
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BRD/10/06-M
Identifier Type: -
Identifier Source: org_study_id