Adding modulated electro‑hyperthermia to total neoadjuvant therapy for locally advanced rectal cancer
The Efficacy of Combination of Modulated Electro-Hyperthermia(mEHT) in The Multimodality Management in Locally Advanced Rectal Cancer: A Multicenter Phase 3 Randomized Control Trial.
This trial tests whether adding modulated electro‑hyperthermia (mEHT) to total neoadjuvant therapy helps adults with locally advanced rectal cancer achieve more tumor down‑staging and higher rates of complete pathological response.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 126 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | Dalin Tzu Chi General Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Chiayi City, Dalin Township) |
| Trial ID | NCT07372300 on ClinicalTrials.gov |
What this trial studies
This is a Phase 3, open‑label, randomized (1:1) trial comparing total neoadjuvant therapy (TNT) plus modulated electro‑hyperthermia (mEHT) versus TNT alone in patients with locally advanced rectal adenocarcinoma. mEHT is delivered with the Oncotherm EHY‑2030 device twice weekly during the chemoradiotherapy portion, using 13.56 MHz electromagnetic energy to raise local tumor temperature to about 39–42°C. The trial's main outcomes include tumor down‑staging (ypT and ypN), pathological complete response (pCR), and longer‑term outcomes such as disease‑free survival. Multiple institutions participate, with patients randomized to receive either TNT with adjunctive mEHT or standard TNT alone.
Who should consider this trial
Good fit: Adults aged 20 years or older with pathologically confirmed locally advanced rectal adenocarcinoma (cT3 with high‑risk features, cT3N1‑2, or cT4N0‑2) without distant metastasis and who are recommended for TNT are eligible.
Not a fit: Patients with distant metastatic disease, those who are not candidates for TNT, or those with contraindications to local electromagnetic hyperthermia are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, adding mEHT could increase tumor regression before surgery and raise rates of pathological complete response, potentially improving long‑term outcomes.
How similar studies have performed: Smaller hyperthermia studies and non‑randomized reports have suggested improved radiosensitivity and response rates, but large randomized Phase 3 evidence specifically for modulated electro‑hyperthermia is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age: 20 years and above 2. Gender: Not restricted 3. Initial pathological diagnosis of adenocarcinoma of the rectum 4. Expected survival ≥ six months 5. Clinical staging of cT3N0 with high recurrence risk or cT3N1-2 or cT4N0-2 rectal cancer, requiring neoadjuvant therapy, without distant metastasis; must meet the following tumor definitions \[staging system according to the 8th edition of the AJCC staging manual\]: 1. cT3: Tumor invades through the muscularis propria into pericolorectal tissues 2. cT4a: Tumor invades through the visceral peritoneum (including gross perforation of the bowel through tumor and continuous invasion of tumor through areas of inflammation to the surface of the visceral peritoneum) 3. cT4b: Tumor directly invades or adheres to adjacent organs or structures \*High recurrence risk factors: cT3 tumor ≤ 5 cm from the anal verge or MRI showing circumferential resection margin (CRM) \< 0.2 cm; cT4 tumor or cN2, presence of MRI showing extramural vascular invasion. 7\. ECOG performance status: 0 - 2 8. Healthy condition suitable for standard treatment, including 25 to 30 fractions of long-course radiotherapy and concurrent chemotherapy (capecitabine or fluorouracil) and subsequent 4- to 6-month chemotherapy, including modified FOLFOX-6 or CAPEOX 9. Willingness to participate in the clinical trial and signed the informed consent form for the protocol. Exclusion Criteria: * (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 * Other systemic autoimmune diseases 9. History of any physical or mental disorder resulting the patient unable to understand or comply with trial requirements, or diminished social communication ability, or unable to provide informed consent 10. Known allergic reaction to trial medications 11. Pregnant or breastfeeding women 12. Substance or alcohol dependence within six months before screening 13. Inability to comply with treatment, assessments, or follow-up
Where this trial is running
Chiayi City, Dalin Township
- Dalin Tzu Chi Hospital — Chiayi City, Dalin Township, Taiwan (Recruiting)
Study contacts
- Study coordinator: Pei-Yu Hsu, Master
- Email: dorishsu1071013@gmail.com
- Phone: +886+5+2648000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.