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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Hepatocellular Carcinoma,

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Trial Information

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


: Phase II controlled randomized trial, multicentre, comparing the benefit of additive
conformational radiotherapy after therapy with hyperselective chemoembolisation (TACE) with
treatment using three TACE treatments (standard of care).


Inclusion Criteria:



- Age ≥ 18 years of age

- ECOG 0-1

- life expectancy ≥ 6 months

- Hepatocellular carcinoma proven histologically or according to radiological and
biochemical criteria (EASL-AASLD) in cirrhotic patients

- Maximum lesion ≤ 9 cm

- Non-eligible for surgery or percutaneous therapy

- Child-Pugh A or B premature (7 points for the Child-Pugh score)

- ASAT and ALAT < 7 x LSN

- Technical possibility of conformational external radiotherapy

- Technical possibility of TACE

- All the tumoral mass must be able to be treated by TACE

- Written consent signed by the patient

Exclusion Criteria:

- Metastatic illness

- Minimal lesion ≤ 5 cm

- Viral replication B non controlled

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to tumoral progression radiologically (CTScan) measured by mRECIST (Modified Response Evaluation Criteria In Solid Tumor).

Outcome Time Frame:

up to 18 months

Safety Issue:

No

Principal Investigator

Cyrille Feray, Pr

Investigator Role:

Principal Investigator

Investigator Affiliation:

Nantes University Hospital

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

BRD 10/6-M

NCT ID:

NCT01300143

Start Date:

June 2011

Completion Date:

October 2014

Related Keywords:

  • Hepatocellular Carcinoma,
  • Carcinoma
  • Carcinoma, Hepatocellular

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