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

Hepatocellular Carcinoma Clinical Trial

— TACERTE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01300143
• Other study ID #: BRD/10/06-M
• Status: Completed
• Phase: Phase 2
• Start date: June 2011
• Est. completion date: October 26, 2018

Study information

• Verified date: December 2021
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: October 26, 2018
• Est. primary completion date: October 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Other:
• TACE
Control arm will be treated by 2 or 3 cures of TACE DC beads at week 0, 8 and 16 (if required)
• TACE+ RTC
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

Locations

Country	Name	City	State
France	CHU Amiens	Amiens
France	CHU d'Angers	Angers
France	CH Avignon	Avignon
France	Institut Sainte Catherine	Avignon
France	CHU de Bordeaux	Bordeaux
France	AP-HP Henri Mondor	Créteil
France	CHU Dijon	Dijon
France	CHD les Oudairies	La Roche-sur-Yon
France	CHR de Lille Hôpital Claude Huriez	Lille
France	CHU de Lyon	Lyon
France	CHU de Nancy Hôpital Brabois	Nancy
France	CHU Nantes	Nantes
France	CHR Orléans	Orléans
France	AP-HP Paul Brousse Villejuif	Paris
France	Hôpital Tenon	Paris
France	La Pitié-Salpétrière	Paris
France	CHU de Reims	Reims
France	Centre Eugene Marquis	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time of tumor progression radiologically (CTScan) measured by mRECIST (Modified Response Evaluation Criteria In Solid Tumor).		up to 18 months
Secondary	Evaluation of the acute toxicity at the participants		within 90 days after the treatment
Secondary	Evaluation of the late toxicity at the participants		after 90 days of treatment
Secondary	Evaluation of the quality of life (assessed by QLQ-EORT C30)		the day of randomization (week 0), at week 12 and week 24
Secondary	Evaluation of the rate of complete, partial response and stable disease after treatment (by RECIST criteria )		at week 24,week 48 and week 72
Secondary	Compare the health economic implications of these regimens in these patients.		up to18 months (week 72)
Secondary	overall survival		within 3 years after first cure of TACE-DC BEADS