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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
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
Conditions
Interventions
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