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

Phase 2

Completed

• Conditions: Hepatocellular Carcinoma
• Interventions: Other: TACE+ RTC; Other: TACE

• Registration Number: NCT01300143
• Lead Sponsor: 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).

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 Timeline

• Study First Submitted: 2011-02-18
• Study First Submitted QC: 2011-02-18
• Study First Posted: 2011-02-21
• Study Start: 2011-06
• Primary Completion: 2018-10-26
• Study Completion: 2018-10-26
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-23
• Last Update Posted: 2021-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TACE + RTC	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	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.

Primary Outcome Measures

Name	Time	Method
Time of tumor progression radiologically (CTScan) measured by mRECIST (Modified Response Evaluation Criteria In Solid Tumor).	up to 18 months

Secondary Outcome Measures

Name	Time	Method
Evaluation of the quality of life (assessed by QLQ-EORT C30)	the day of randomization (week 0), at week 12 and week 24
overall survival	within 3 years after first cure of TACE-DC BEADS
Evaluation of the late toxicity at the participants	after 90 days of treatment
Evaluation of the acute toxicity at the participants	within 90 days after the treatment
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)

Trial Locations

Locations (18)

CHU de Bordeaux; 🇫🇷 Bordeaux, France

CHU Amiens; 🇫🇷 Amiens, France

Institut Sainte Catherine; 🇫🇷 Avignon, France

CHR Orléans; 🇫🇷 Orléans, France

Centre Eugene Marquis; 🇫🇷 Rennes, France

CH Avignon; 🇫🇷 Avignon, France

AP-HP Henri Mondor; 🇫🇷 Créteil, France

CHR de Lille Hôpital Claude Huriez; 🇫🇷 Lille, France

CHU Nantes; 🇫🇷 Nantes, France

La Pitié-Salpétrière; 🇫🇷 Paris, France

CHD les Oudairies; 🇫🇷 La Roche-sur-Yon, France

CHU de Lyon; 🇫🇷 Lyon, France

CHU de Reims; 🇫🇷 Reims, France

CHU Dijon; 🇫🇷 Dijon, France

CHU de Nancy Hôpital Brabois; 🇫🇷 Nancy, France

Hôpital Tenon; 🇫🇷 Paris, France

CHU d'Angers; 🇫🇷 Angers, France

AP-HP Paul Brousse Villejuif; 🇫🇷 Paris, France