Phase 3 Study of Adding Modulated Electro-Hyperthermia to Standard Total Neoadjuvant Therapy for Adults with Locally Advanced Rectal Cancer

What this Trial Is About

Researchers are evaluating whether adding modulated electro-hyperthermia mEHT to Total Neoadjuvant Therapy TNT can improve tumor down-staging and pathological response in adults aged 20 years and above with locally advanced rectal adenocarcinoma. This Phase 3, open-label study aims to compare TNT alone versus TNT combined with mEHT to see if the addition enhances tumor regression and long-term outcomes such as disease-free survival. Participants are randomly assigned to one of two groups the experimental group receives TNT plus mEHT delivered by the Oncotherm EHY-2030 device twice weekly during the 5-6 week chemoradiotherapy CRT phase, while the control group receives TNT alone. TNT includes 5-6 weeks of chemoradiotherapy followed by 4-6 months of neoadjuvant chemotherapy, and finally surgery called total mesorectal excision TME. Throughout the study, participants will undergo chemoradiotherapy with concurrent medications and radiation, followed by chemotherapy regimens CAPEOX or mFOLFOX 6. Researchers will assess tumor down-staging rates at 9 months, pathological complete response, survival outcomes up to 60 months, and quality of life. Safety and blood cell counts will be monitored at several intervals. The total involvement includes treatment, follow-up assessments, and surgery to evaluate the effectiveness and safety of the combined treatments.

Modulated Electro-Hyperthermia in Combination With Multimodal Therapy for Locally Advanced Rectal Cancer