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.
Age: 20 years and above
Gender: Not restricted
Initial pathological diagnosis of adenocarcinoma of the rectum
Expected survival ≥ six months
(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
Parallel
Hyperthermia
DeviceModulated electro-hyperthermia, 2 times weekly for 6 weeks
Down-staging Rate
Evaluation of the decrease in ypT and ypN staging for patients with locally advanced rectal cancer following the current recommended treatment method, total neoadjuvant therapy (TNT). The ycT and ycN staging will be assessed using MRI within three months post-treatment for patients who do not undergo surgery.
Pathological Complete Response (pCR) Rate.
A pCR must include no gross or microscopic tumor identified anywhere within the surgical specimen. This must include: * No evidence of malignant cells in the primary tumor specimen AND * No evidence of malignant cells in the lymph nodes.
Treatment Response Patterns
Using the Dworak Scale, defined as "good tumor shrinkage" with Grade 3 and Grade 4.
Overall Survival (OS)
OS is defined as time from randomization to the date of death due to any cause.
Disease-Free Survival (DFS)
DFS is defined as the time from randomization to the date of local recurrence, regional recurrence, distant recurrence or death due to all causes whichever comes first. Patients who fail to return for evaluation after beginning therapy will be censored for DFS on the last day of therapy.
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Shih-Kai Hung
Lead sponsor
Dalin Tzu Chi General Hospital
Sponsor institution
Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Collaborator
