Phase III Randomized Study Comparing Adjuvant Radiation Therapy Versus Monitoring in High-Risk Cutaneous Squamous Cell Carcinoma Patients

What this Trial Is About

Researchers are investigating the best approach to treat patients with cutaneous squamous cell carcinoma CSCC who have a high risk of the cancer returning after surgery. This study compares two strategies adding radiation therapy after surgery called adjuvant radiotherapy versus closely monitoring patients without immediate additional treatment. The goal is to see if disease-free survival DFS, which means the time patients remain free from cancer recurrence, differs between these two approaches. Participants will be randomly assigned to one of two groups. One group will receive radiation therapy starting within 8 to 12 weeks after surgery, delivering a total dose of 45 to 50 Gy to the area where the tumor was removed. Radiation may be given externally with high-energy photons or electrons, or through brachytherapy. The other group will undergo regular monitoring without additional treatment after surgery. Both groups will continue follow-up until cancer recurrence or death, with decisions for any further treatment left to the treating physician. Participants will be followed every 4 months for the first 2 years and then every 6 months thereafter. During visits, doctors will perform clinical exams, review any other treatments the patient is receiving, conduct imaging tests, and assess quality of life through questionnaires. The study will track outcomes such as disease-free survival, local and regional recurrence, metastatic recurrence, overall survival, treatment tolerance, and quality of life. Follow-up will continue until death or progression of disease, with assessments up to 36 months for many outcomes.

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