Study of a Strategy Integrating Adjuvant Radiation Therapy Versus Strategy Based on Monitoring in the Treatment of Carcinomas Spinocellular With High Risk of Recurrence
Randomized Comparative Multicenter Phase III Study of a Strategy Integrating Adjuvant Radiation Therapy Versus Strategy Based on Monitoring in the Treatment of Carcinomas Spinocellular With High Risk of Recurrence
Centre Leon Berard
266 participants
Feb 21, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria10
- 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 Criteria8
- 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.
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Interventions
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.
Locations(28)
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NCT06692556