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NOT YET RECRUITING
NCT06692556
PHASE3

Study of a Strategy Integrating Adjuvant Radiation Therapy Versus Strategy Based on Monitoring in the Treatment of Carcinomas Spinocellular With High Risk of Recurrence

Sponsor: Centre Leon Berard

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to evaluate a strategy integrating adjuvant radiation therapy versus strategy based on monitoring in the treatment of carcinomas spinocellular with high risk of recurrence (SCC). The investigators will compare the disease-free survival (DFS) of patients treated with adjuvant radiation therapy versus surveillance in high risk of recurrence SCC. The main question it aims to answer is: Is DFS different between the "adjuvant radiotherapy" group and the "surveillance" group? Participants will: * be distributed in one of the two arms * will be followed up every 4 months for 2 years, then every 6 months (clinical examination, identification of concomitant treatments, imaging, quality-of-life questionnaire) * followed up until their death or their progression whether local, regional or metastatic

Official title: Randomized Comparative Multicenter Phase III Study of a Strategy Integrating Adjuvant Radiation Therapy Versus Strategy Based on Monitoring in the Treatment of Carcinomas Spinocellular With High Risk of Recurrence

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

266

Start Date

2024-12

Completion Date

2029-06

Last Updated

2024-11-20

Healthy Volunteers

No

Interventions

RADIATION

Adjuvant radiotherapy

Patients will receive an adjuvant radiotherapy corresponding to an equivalent dose of 45 to 50 Gy (Equivalent Dose in 2 Gy Fractions \[EQD2\] with a tumor alpha/beta ratio of 10 Gy) delivered on the operating bed. Patients will be treated by : * either external radiation therapy using high-energy electrons or photons: * 45 Gy in 15 fractions of 3 Gy * 50 Gy in 25 fractions of 2 Gy * or interstitial brachytherapy or brachytherapy via skin applicators: * 36 Gy in 8 fractions of 4.5 Gy * 36 Gy in 9 fractions of 4 Gy * 40 Gy in 8 fractions of 5 Gy Radiation therapy should be started within 8 weeks after surgery (or 10 if delayed healing). Patients will be monitored regularly until the date of the first relapse (local, regional or metastatic), or until the date of death (if no relapse). Regardless of the type of relapse, remedial treatments will be left to the the investigator's discretion up to the first metastatic relapse.

Locations (22)

Centre Georges François Leclerc

Dijon, Côte-d'Or, France

Centre Hospitalier Romans - Hopitaux Drôme Nord

Romans-sur-Isère, Drôme, France

Centre de Radiothérapie Marie Curie

Valence, Drôme, France

Centre Hospitalier de Valence

Valence, Drôme, France

Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan

Brest, Finistère, France

Centre Hospitalier Universitaire de Bordeaux

Pessac, Gironde, France

Centre Hospitalier Annecy Genevois

Épagny-Metz-Tessy, Haute-Savoie, France

Centre Hospitalier Universitaire de Rennes

Rennes, Ille-et-Vilaine, France

Centre Hospitalier Universitaire de Grenoble-Alpes

La Tronche, Isère, France

Centre Hospitalier Simone Veil de Blois

Blois, Loir-et-Cher, France

Centre Hospitalier Universitaire de Nantes - Hôtel-Dieu

Nantes, Loire-Atlantique, France

Institut Godinot

Reims, Marne, France

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, MMeurthe-et-Moselle, France

Groupe Hospitalier Bretagne Sud

Lorient, Morbihan, France

Centre hospitalier de Roanne

Roanne, Pays de la Loire Region, France

Centre Hospitalier Universitaire de Saint-Etienne - Hôpital Nord

Saint Priest En Jarez, Pays de la Loire Region, France

Centre Hospitalier Universitaire Estaing

Clermont-Ferrand, Puy-de-Dôme, France

Centre Hospitalier Universitaire Rouen - Hôpital Charles Nicolle

Rouen, Seine-Maritime, France

Centre Hospitalier Universitaire Amiens-Picardie

Amiens, Somme, France

Hôpital d'instruction des armées Sainte-Anne

Toulon, Var, France

Centre Léon Bérard

Lyon, France

Hôpital Bichat Claude-Bernard

Paris, Île-de-France Region, France