AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

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

RecruitingPhase 3Ages 18 Years - anyAllCentre Leon Berard
💬

In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 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). Exclusion Criteria: 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.
💊

What it tests

  • Adjuvant radiotherapy
📍

Where

28 sites
Centre Hospitalier Emile Roux
Le Puy-en-Velay, France
Hospices Civils de Lyon - Centre Hospitalier Lyon Sud
Pierre-Bénite, France
Centre Georges François Leclerc
Dijon, France
Centre Hospitalier Romans - Hopitaux Drôme Nord
Romans-sur-Isère, France
Centre de Radiothérapie Marie Curie
Valence, France
Centre Hospitalier de Valence
Valence, France
Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan
Brest, France
Hôpital de la Cavale Blanche
Brest, France

…and 20 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy