NCT06692556 Study of a Strategy Integrating Adjuvant Radiation Therapy Versus Strategy Based on Monitoring in the Treatment of Carcinomas Spinocellular With High Risk of Recurrence
| NCT ID | NCT06692556 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Centre Leon Berard |
| Condition | Cutaneous Squamous Cell Carcinoma (CSCC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 266 participants |
| Start Date | 2025-02-21 |
| Primary Completion | 2031-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 266 participants in total. It began in 2025-02-21 with a primary completion date of 2031-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Eligibility Criteria
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.
Contact & Investigator
Mona AMINI-ADLE, Dr
PRINCIPAL INVESTIGATOR
Centre Leon Berard
Frequently Asked Questions
Who can join the NCT06692556 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cutaneous Squamous Cell Carcinoma (CSCC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06692556 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 266 participants.
Is NCT06692556 currently recruiting?
Yes, NCT06692556 is actively recruiting participants. Contact the research team at julien.gautier@lyon.unicancer.fr for enrollment information.
Where is the NCT06692556 trial being conducted?
This trial is being conducted at Le Puy-en-Velay, France, Pierre-Bénite, France, Dijon, France, Romans-sur-Isère, France and 11 additional locations.
Who is sponsoring the NCT06692556 clinical trial?
NCT06692556 is sponsored by Centre Leon Berard. The principal investigator is Mona AMINI-ADLE, Dr at Centre Leon Berard. The trial plans to enroll 266 participants.