Heat waves against cancer: new trial tests hyperthermia for rectal tumors
NCT ID NCT07372300
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This phase 3 trial tests whether adding modulated electro-hyperthermia (mEHT) to standard treatment helps shrink locally advanced rectal cancer. About 126 adults will receive either standard therapy alone or with mEHT twice a week for six weeks. The goal is to see if the heat-based treatment improves tumor down-staging and complete response rates.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- modulated electro-hyperthermia (mEHT) using the Oncotherm EHY-2030 device
- What this could lead to
- If it works, this could offer a way to shrink rectal tumors more effectively before surgery, potentially improving outcomes and reducing recurrence.
- What could go wrong
- This is a mid-stage trial with only 126 participants, so results may not apply broadly. The added hyperthermia could cause discomfort or skin burns, and it may not improve response over standard therapy.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 126 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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20 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Dalin Tzu Chi Hospital
RECRUITINGChiayi City, Dalin Township, 600401, Taiwan
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