Clinical trial NCT01300143: Association of Conformational High-dose Radiotherapy and of Hyperselective Transarterial Chemoembolization in the Treatment of Hepatocellular Carcinoma
Official title: Association of Conformational High-dose Radiotherapy and of Hyperselective Transarterial Chemoembolization in the Treatment of Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2011-02-21
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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 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

Primary outcomes:
measure: Time of tumor progression radiologically (CTScan) measured by mRECIST (Modified Response Evaluation Criteria In Solid Tumor).
timeFrame: up to 18 months
Secondary outcomes:
measure: Evaluation of the acute toxicity at the participants
timeFrame: within 90 days after the treatment
measure: Evaluation of the late toxicity at the participants
timeFrame: after 90 days of treatment
measure: Evaluation of the quality of life (assessed by QLQ-EORT C30)
timeFrame: the day of randomization (week 0), at week 12 and week 24
measure: Evaluation of the rate of complete, partial response and stable disease after treatment (by RECIST criteria )
timeFrame: at week 24,week 48 and week 72
measure: Compare the health economic implications of these regimens in these patients.
timeFrame: up to18 months (week 72)
measure: overall survival
timeFrame: within 3 years after first cure of TACE-DC BEADS
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
city: Angers
country: France
facility: CHU d'Angers
city: Avignon
country: France
facility: CH Avignon
city: Avignon
country: France
facility: Institut Sainte Catherine
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Créteil
country: France
facility: AP-HP Henri Mondor
city: Dijon
country: France
facility: CHU Dijon
city: La Roche-sur-Yon
country: France
facility: CHD les Oudairies
city: Lille
country: France
facility: CHR de Lille Hôpital Claude Huriez
city: Lyon
country: France
facility: CHU de Lyon
city: Nancy
country: France
facility: CHU de Nancy Hôpital Brabois
city: Nantes
country: France
facility: CHU Nantes
city: Orléans
country: France
facility: CHR Orléans
city: Paris
country: France
facility: AP-HP Paul Brousse Villejuif
city: Paris
country: France
facility: Hôpital Tenon
city: Paris
country: France
facility: La Pitié-Salpétrière
city: Reims
country: France
facility: CHU de Reims
city: Rennes
country: France
facility: Centre Eugene Marquis
Study officials:
affiliation: Henri Mondor Hospital (Paris)
name: Cyrille Feray, Pr
role: PRINCIPAL_INVESTIGATOR
References: