Actively Recruiting
Study of a Strategy Integrating Adjuvant Radiation Therapy Versus Strategy Based on Monitoring in the Treatment of Carcinomas Spinocellular With High Risk of Recurrence
Led by Centre Leon Berard · Updated on 2026-04-24
266
Participants Needed
28
Research Sites
327 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Study of a Strategy Integrating Adjuvant Radiation Therapy Versus Strategy Based on Monitoring in the Treatment of Carcinomas Spinocellular With High Risk of Recurrence
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 60; 18 years at the time of signing the informed consent form
- Histologically confirmed localized cutaneous squamous cell carcinoma
- Patients treated with complete surgical excision (R0), regardless of margin size
- Disease with high risk of recurrence defined by presence of microscopic EPN with or without other risk factors, or multiple other risk factors such as immunosuppression, tumor diameter >20 mm, specific location (lip/ear/temple), deep invasion, poor differentiation, or desmoplasia
- Patient informed and having signed a consent form to participate in the study
- Patient enrolled in a health insurance plan (or beneficiary of such a plan)
You will not qualify if you...
- Patients with in situ or mixed cutaneous squamous cell carcinoma
- History of cutaneous squamous cell carcinoma with high risk of recurrence in the same lymphatic drainage area within 2 years prior to randomization
- History of cutaneous squamous cell carcinoma treated with systemic therapy
- SCC localized to the endonasal, intraoral, anogenital, or vulvar mucosa
- Patients with recurrent SCC or SCC at very high risk of recurrence defined by EPN with 60; 2 other risk factors, >3 risk factors, bone invasion, or immunosuppression due to immunosuppressive treatments
- Patients with cutaneous squamous cell carcinoma presenting a single risk factor other than EPN
- Patients with lymph node or distant metastasis
- Patients undergoing systemic and/or locoregional anticancer treatment for any cancer
- Contraindication to radiation therapy
- History of radiation therapy to the site of the lesion
- Participation in another clinical trial that may interfere with the primary endpoint assessment
- Patient under legal guardianship or conservatorship, or deprived of liberty
- Pregnant or breastfeeding women
AI-Screening
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Trial Site Locations
Total: 28 locations
1
Centre Hospitalier Emile Roux
Le Puy-en-Velay, Auvergne-Rhône-Alpes, France, 43000
Withdrawn
2
Hospices Civils de Lyon - Centre Hospitalier Lyon Sud
Pierre-Bénite, Auvergne-Rhône-Alpes, France, 69495
Not Yet Recruiting
3
Centre Georges François Leclerc
Dijon, Bourgogne-Franche-Comté, France, 21079
Active, Not Recruiting
4
Centre Hospitalier Romans - Hopitaux Drôme Nord
Romans-sur-Isère, Drôme, France, 26102
Actively Recruiting
5
Centre de Radiothérapie Marie Curie
Valence, Drôme, France, 26000
Not Yet Recruiting
6
Centre Hospitalier de Valence
Valence, Drôme, France, 26000
Actively Recruiting
7
Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan
Brest, Finistère, France, 29200
Withdrawn
8
Hôpital de la Cavale Blanche
Brest, Finistère, France, 29200
Not Yet Recruiting
9
Centre Hospitalier Universitaire de Bordeaux
Pessac, Gironde, France, 33604
Active, Not Recruiting
10
Centre Hospitalier Annecy Genevois
Metz-Tessy, Haute-Savoie, France, 74374
Actively Recruiting
11
Centre Hospitalier Universitaire de Rennes
Rennes, Ille-et-Vilaine, France, 35033
Not Yet Recruiting
12
Centre Hospitalier Universitaire de Grenoble-Alpes
La Tronche, Isère, France, 38700
Not Yet Recruiting
13
Centre Hospitalier Simone Veil de Blois
Blois, Loir-et-Cher, France, 41016
Actively Recruiting
14
Centre Hospitalier Universitaire de Nantes - Hôtel-Dieu
Nantes, Loire-Atlantique, France, 44093
Actively Recruiting
15
Institut Godinot
Reims, Marne, France, 51726
Active, Not Recruiting
16
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, MMeurthe-et-Moselle, France, 54519
Actively Recruiting
17
Groupe Hospitalier Bretagne Sud
Lorient, Morbihan, France, 56322
Actively Recruiting
18
CHU de Bordeaux - Hôpital Saint André
Bordeaux, New Aquitaine, France, 33076
Not Yet Recruiting
19
Centre De Radiothérapie Guillaume Le Conquérant
Le Havre, Normandy, France, 76600
Not Yet Recruiting
20
Centre hospitalier de Roanne
Roanne, Pays de la Loire Region, France, 42300
Actively Recruiting
21
Centre Hospitalier Universitaire de Saint-Etienne - Hôpital Nord
Saint Priest En Jarez, Pays de la Loire Region, France, 42271
Actively Recruiting
22
Centre Antoine Lacassagne
Nice, Provence-Alpes-Côte d'Azur Region, France, 06189
Not Yet Recruiting
23
Centre Hospitalier Universitaire Estaing
Clermont-Ferrand, Puy-de-Dôme, France, 63033
Actively Recruiting
24
Centre Hospitalier Universitaire Rouen - Hôpital Charles Nicolle
Rouen, Seine-Maritime, France, 76031
Not Yet Recruiting
25
Centre Hospitalier Universitaire Amiens-Picardie
Amiens, Somme, France, 80054
Active, Not Recruiting
26
Hôpital d'instruction des armées Sainte-Anne
Toulon, Var, France, 83800
Withdrawn
27
Centre Léon Bérard
Lyon, France, 69373
Actively Recruiting
28
Hôpital Bichat Claude-Bernard
Paris, Île-de-France Region, France, 75877
Active, Not Recruiting
Research Team
J
Julien GAUTIER
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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