About this trial
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
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Adjuvant radiotherapy