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
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;
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;
Parallel
Adjuvant radiotherapy
RadiationPatients 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.
Disease-Free Survival (DFS)
DFS is defined as the time from the date of randomization to the date of recurrence (local, lymph node or metastatic) or death from any cause. A new skin lesion will not be considered a statistical event. Patients without an event at the date of analysis will be censored at the last date of new disease-free status. DFS will be estimated by the Kaplan Meier method and described in terms of median in each arm. DFS distributions will be compared between arms using a Log-Rank test. The hazard ratio from a Cox model will be calculated and presented with its 95% confidence interval. The rate of patients without recurrence at 1 and 2 years post-randomization will also be presented with their associated confidence interval.
Local recurrence-free survival (lrFS)
lrFS is defined as the time from randomization (or surgery) to the first occurrence of regional recurrence or death from any cause.
Regional Recurrence-Free Survival (RrFS)
RrFS is The time from randomization (or surgery) to the first occurrence of regional recurrence or death from any cause, whichever came first
Metastatic recurrence-free survival (MrFS)
MrFS is defined as the time elapsed between the date of randomization and the date of metastatic recurrence or death from any cause. Patients without an event at the analysis date will be censored at the last date of news without metastatic disease.
Overall Survival (OS)
OS is defined as the time from the date of randomization to the date of death from any cause. Patients without an event at the analysis date will be censored at the last date of death-free news.
Progression-free survival after loco-regional recurrence salvage therapy in the Surveillance group
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