Association of Conformational High-dose Radiotherapy and of Hyperselective Transarterial Chemoembolization in the Treatment of Hepatocellular Carcinoma (TACERTE)
This study is currently recruiting participants.
Verified February 2013 by Nantes University Hospital
Sponsor:
Nantes University Hospital
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01300143
First received: February 18, 2011
Last updated: February 15, 2013
Last verified: February 2013
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Purpose
Indication : Hepatocellular carcinoma, maximum size 9 cm, with single or multiple nodes whose total tumoural mass can technically be irradiated, non-resectable, and not a candidate for percutaneous therapy with recommended treatment via hyperselective transarterial chemoembolisation (TACE).
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatocellular Carcinoma, |
Other: TACE Other: TACE+ RTC |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Association of Conformational High-dose Radiotherapy and of Hyperselective Transarterial Chemoembolization in the Treatment of Hepatocellular Carcinoma |
Further study details as provided by Nantes University Hospital:
Primary Outcome Measures:
- Time to tumoral progression radiologically (CTScan) measured by mRECIST (Modified Response Evaluation Criteria In Solid Tumor). [ Time Frame: up to 18 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Evaluation of the acute toxicity at the participants [ Time Frame: in 90 days follow the treatment ] [ Designated as safety issue: Yes ]
- Evaluation of the late toxicity at the participants [ Time Frame: after 90 days of treatment ] [ Designated as safety issue: Yes ]
- Evaluation of the quality of life (assessed by QLQ-EORT C30) [ Time Frame: the day of randomization and at 6 months ] [ Designated as safety issue: No ]
- Evaluation of the rate of complete answers and partial answers after treatment ( by RECIST criteria ) [ Time Frame: up to 18 months ] [ Designated as safety issue: No ]
- Compare the health economic implications of these regimens in these patients. [ Time Frame: up to18months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 174 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | October 2014 |
| Estimated Primary Completion Date: | October 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: TACE
Patients will be treated by 2 or 3 hyperselectives TACE at 0, 2 and 4 months.
|
Other: TACE
Control arm will be treated by 3 TACE DC beads at 0, 2 and 4 months
|
|
Experimental: RTC
Patients will be treated by one cure of TACE then, in the two weeks, by external conformational radiotherapy of 54 grey fractioned in 18 sessions during 3-4 weeks.
|
Other: TACE+ RTC
Experimental group will be treated by one cure of TACE DC Beads then, two weeks later, by external conformational radiotherapy in 18 sessions
|
Detailed Description:
: 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).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01300143
Contacts
| Contact: Cyrille Feray, PHD | cyrille.feray@chu-nantes.fr |
Locations
| France | |
| CHU d'Angers | Recruiting |
| Angers, France | |
| Principal Investigator: Paul CALES, PR | |
| CHU de Bordeaux | Not yet recruiting |
| Bordeaux, France | |
| Contact: Jean Fréderic Blanc, PU-PH | |
| Principal Investigator: Jean Fréderic Leblanc | |
| AP-HP Henri Mondor | Recruiting |
| Créteil, France | |
| Principal Investigator: Thomas DECAENS, MD | |
| CHD les Oudairies | Recruiting |
| La Roche/Yon, France | |
| Principal Investigator: FAROUX r FAROUX, MD | |
| CHR de Lille Hôpital Claude Huriez | Recruiting |
| Lille, France | |
| Principal Investigator: Philippe MATHURIN, Pr | |
| CHU de Lyon | Recruiting |
| Lyon, France | |
| Principal Investigator: Philippe MERLE, Pr | |
| CHU de Nancy Hôpital Brabois | Not yet recruiting |
| Nancy, France | |
| Principal Investigator: JP BRONOWICKI, Pr | |
| CHU Nantes | Recruiting |
| Nantes, France | |
| Contact: Cyrille Feray, MD PHD | |
| AP-HP Paul Brousse Villejuif | Not yet recruiting |
| Paris, France | |
| Principal Investigator: Didier SAMUEL, Pr | |
Sponsors and Collaborators
Nantes University Hospital
Investigators
| Principal Investigator: | Cyrille Feray, Pr | Nantes University Hospital |
More Information
No publications provided
| Responsible Party: | Nantes University Hospital |
| ClinicalTrials.gov Identifier: | NCT01300143 History of Changes |
| Other Study ID Numbers: | BRD 10/6-M |
| Study First Received: | February 18, 2011 |
| Last Updated: | February 15, 2013 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma |
Liver Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases |
ClinicalTrials.gov processed this record on June 13, 2013