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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).
: 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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TACE | Active Comparator | 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. |
|
| TACE + RTC | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TACE | Other | Control arm will be treated by 2 or 3 cures of TACE DC beads at week 0, 8 and 16 (if required) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time of tumor progression radiologically (CTScan) measured by mRECIST (Modified Response Evaluation Criteria In Solid Tumor). | up to 18 months |
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cyrille Feray, Pr | Henri Mondor Hospital (Paris) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Amiens | Amiens | France | ||||
| CHU d'Angers |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36937990 | Derived | Feray C, Campion L, Mathurin P, Archambreaud I, Mirabel X, Bronowicki JP, Rio E, Perret C, Mineur L, Oberti F, Touchefeu Y, Gournay J, Regnault H, Edeline J, Rode A, Hillion P, Blanc JF, Khac EN, Azoulay D, Luciani A, Preglisasco AG, Faurel-Paul E, Auble H, Mornex F, Merle P. TACE and conformal radiotherapy vs. TACE alone for hepatocellular carcinoma: A randomised controlled trial. JHEP Rep. 2023 Jan 29;5(4):100689. doi: 10.1016/j.jhepr.2023.100689. eCollection 2023 Apr. |
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| TACE+ RTC | Other | 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 |
|
| 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 |
| 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 | France |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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