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

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

266

Participants

Timeline

Start Date

December 31, 2024

Primary Completion Date

June 30, 2029

Study Completion Date

June 30, 2029

Conditions
Cutaneous Squamous Cell Carcinoma (CSCC)
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."

Trial Locations (22)

21079

Centre Georges François Leclerc, Dijon

26000

Centre de Radiothérapie Marie Curie, Valence

Centre Hospitalier de Valence, Valence

26102

Centre Hospitalier Romans - Hopitaux Drôme Nord, Romans-sur-Isère

29200

Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan, Brest

33604

Centre Hospitalier Universitaire de Bordeaux, Pessac

35033

Centre Hospitalier Universitaire de Rennes, Rennes

38700

Centre Hospitalier Universitaire de Grenoble-Alpes, La Tronche

41016

Centre Hospitalier Simone Veil de Blois, Blois

42271

Centre Hospitalier Universitaire de Saint-Etienne - Hôpital Nord, Saint Priest En Jarez

42300

Centre hospitalier de Roanne, Roanne

44093

Centre Hospitalier Universitaire de Nantes - Hôtel-Dieu, Nantes

51726

Institut Godinot, Reims

54519

Institut de Cancérologie de Lorraine, Vandœuvre-lès-Nancy

56322

Groupe Hospitalier Bretagne Sud, Lorient

63033

Centre Hospitalier Universitaire Estaing, Clermont-Ferrand

69373

Centre Léon Bérard, Lyon

74374

Centre Hospitalier Annecy Genevois, Épagny-Metz-Tessy

75877

Hôpital Bichat Claude-Bernard, Paris

76031

Centre Hospitalier Universitaire Rouen - Hôpital Charles Nicolle, Rouen

80054

Centre Hospitalier Universitaire Amiens-Picardie, Amiens

83800

Hôpital d'instruction des armées Sainte-Anne, Toulon

All Listed Sponsors
lead

Centre Leon Berard

OTHER