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

Study Overview
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Brief Summary
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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
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: 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).

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

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Other: TACE
* Other: TACE+ RTC


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TACE<br>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. | Other: TACE<br>* Control arm will be treated by 2 or 3 cures of TACE DC beads at week 0, 8 and 16 (if required)<br>|
| Experimental: TACE + RTC<br>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. | Other: TACE+ RTC<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of tumor progression radiologically (CTScan) measured by mRECIST (Modified Response Evaluation Criteria In Solid Tumor). |  | up to 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| overall survival |  | within 3 years after first cure of TACE-DC BEADS |