About this trial
The goal of this clinical trial is to investigate if the addition of modulated electro-hyperthermia (mEHT) improves tumor down-staging and pathological response in adult patients (20 years and above) with locally advanced rectal adenocarcinoma (cT3N0M0 with high risk of recurrence, cT3N1-2M0, or cT4N0-2M0). The main questions it aims to answer are:
* Does the addition of mEHT to the Total Neoadjuvant Therapy (TNT) regimen significantly increase the rate of tumor down-staging (ypT and ypN) compared to TNT alone? * Does the combination therapy improve the pathological complete response (pCR) rate and long-term outcomes (such as disease-free survival) compared to standard TNT?
Researchers will compare participants randomized to receive Total Neoadjuvant Therapy (TNT) plus mEHT using the Oncotherm EHY-2030 device to participants receiving TNT alone to see if the adjunctive mEHT therapy enhances tumor regression and improves patient prognosis. Participants will be randomized (1:1) into one of the two groups and will undergo the following regimen:
* Receive standard TNT, which includes 5-6 weeks of chemoradiotherapy (CRT) followed by 4-6 months of neoadjuvant chemotherapy. * Patients in the experimental group will receive mEHT twice a week during the CRT period.
Eligibility criteria
Qualifiers
Age: 20 years and above
Gender: Not restricted
Initial pathological diagnosis of adenocarcinoma of the rectum
Expected survival ≥ six months
Disqualifiers
(e) Active infection or severe underlying disease making the patient unsuitable for the trial treatments
Known HIV infection
Untreated thyroid disease
Active Crohn's disease or ulcerative colitis
Trial design
Treatments tested in this trial
- Hyperthermia
Treatment groups
Sponsors and collaborators
Shih-Kai Hung
Lead sponsor
Dalin Tzu Chi General Hospital
Sponsor institution
Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Collaborator