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

Nantes University Hospital (NUH)

Status and phase: Completed; Phase 2

Conditions: Hepatocellular Carcinoma

Treatments: Other: TACE+ RTC; Other: TACE

Study type: Interventional

Funder types: Other

Identifiers

NCT01300143

BRD/10/06-M

Details and patient eligibility

About

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).

Full 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).

Enrollment: 126 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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126 participants in 2 patient groups

TACE

Active Comparator group

Description:

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.

Treatment:

Other: TACE

TACE + RTC

Experimental group

Description:

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.

Treatment:

Other: TACE+ RTC