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

Recruiting now · Phase 3

Conditions studied: Cutaneous Squamous Cell Carcinoma (CSCC)

In brief

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

Key facts

Study ID

NCT06692556

Run by

Centre Leon Berard

People needed

266

Starts

2025-02-21

Expected to finish

2031-06-01

Last updated by the study team

2026-04-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• I1. Patients aged ≥ 18 years at the time of signing the informed consent form; I2. Patients with histologically confirmed localized cutaneous squamous cell carcinoma;
• Note: Patients with carcinoma of the external auditory canal may be included in the study;
• I3. Patients treated with complete surgical excision (R0), regardless of the margin (submillimeter or supramillimeter);
• I4. Disease with a high risk of recurrence defined by one of the following scenarios:
• presence of microscopic EPN without any other risk factors;
• presence of microscopic EPN with a single other risk factor;
• presence of 2 risk factors other than microscopic EPN;
• presence of 3 risk factors other than microscopic EPN;
• Note: The risk factors considered are immunosuppression (limited to untreated hematologic disease), a tumor diameter >20 mm (longest axis, measured preferably clinically, or, failing that, histologically), a specific location (lip/ear/temple), deep invasion (tumor thickness >6 mm (Breslow) or invasion beyond the subcutaneous fat), poor differentiation, or desmoplasia;
• I5. Patient informed and having signed a consent form to participate in the study; I6. Patient enrolled in a health insurance plan (or beneficiary of such a plan).

You may not qualify if…

• NI1. Patients with in situ or mixed CEC; NI2. History of CEC with a high risk of recurrence in the same lymphatic drainage area (head and neck, trunk, or limb) within 2 years prior to the randomization date; NI3. History of CEC treated with systemic therapy; NI4. Patients with SCC localized to the endonasal, intraoral, anogenital, or vulvar mucosa;
• NI5. Patients with recurrent SCC or SCC at very high risk of recurrence defined by one of the following criteria:
• EPN with ≥ 2 other risk factors,
• > 3 risk factors,
• bone invasion,
• immunosuppression due to immunosuppressive treatments (regardless of the reason). NI6. Patients with CEC presenting a single risk factor other than EPN; NI7. Patient with CEC and lymph node or distant metastasis; NI8. Patient with a history of cancer undergoing systemic and/or locoregional anticancer treatment;
• Note: Local treatment of cutaneous keratoses with fluoropyrimidines is permitted outside the theoretical radiation field);
• NI9. Patient with a contraindication to radiation therapy; NI10. Patient with a history of radiation therapy to the site of the lesion; NI11. Participation in another clinical trial that may interfere with the assessment of the primary endpoint; NI12. Patient under legal guardianship or conservatorship, or deprived of liberty; NI13. Pregnant or breastfeeding woman.

Where it is running

• Centre Hospitalier de Valence — Valence, Drôme, France (enrolling)
• Centre Hospitalier Romans - Hopitaux Drôme Nord — Romans-sur-Isère, Drôme, France (enrolling)
• Centre hospitalier de Roanne — Roanne, Pays de la Loire Region, France (enrolling)
• Centre Hospitalier Universitaire de Saint-Etienne - Hôpital Nord — Saint Priest En Jarez, Pays de la Loire Region, France (enrolling)
• Centre Hospitalier Simone Veil de Blois — Blois, Loir-et-Cher, France (enrolling)
• Centre Hospitalier Universitaire Estaing — Clermont-Ferrand, Puy-de-Dôme, France (enrolling)
• Centre Hospitalier Universitaire de Nantes - Hôtel-Dieu — Nantes, Loire-Atlantique, France (enrolling)
• Centre Hospitalier Annecy Genevois — Metz-Tessy, Haute-Savoie, France (enrolling)
• Institut de Cancérologie de Lorraine — Vandœuvre-lès-Nancy, MMeurthe-et-Moselle, France (enrolling)
• Centre Léon Bérard — Lyon, France (enrolling)
• Groupe Hospitalier Bretagne Sud — Lorient, Morbihan, France (enrolling)
• Centre De Radiothérapie Guillaume Le Conquérant — Le Havre, Normandy, France
• Centre Antoine Lacassagne — Nice, Provence-Alpes-Côte d'Azur Region, 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 Hospitalier Emile Roux — Le Puy-en-Velay, Auvergne-Rhône-Alpes, France
• Hôpital Bichat Claude-Bernard — Paris, Île-de-France Region, France
• Hospices Civils de Lyon - Centre Hospitalier Lyon Sud — Pierre-Bénite, Auvergne-Rhône-Alpes, France
• Centre Georges François Leclerc — Dijon, Bourgogne-Franche-Comté, France
• Centre de Radiothérapie Marie Curie — Valence, Drôme, France
• Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan — Brest, Finistère, France
• Hôpital de la Cavale Blanche — Brest, Finistère, France
• Centre Hospitalier Universitaire de Bordeaux — Pessac, Gironde, France
• Centre Hospitalier Universitaire de Rennes — Rennes, Ille-et-Vilaine, France

Full record on ClinicalTrials.gov

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