Adding modulated electro‑hyperthermia to total neoadjuvant therapy for locally advanced rectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Triplet vs doublet induction therapy with chemoradiotherapy for high-risk locally advanced rectal cancer, followed by surgery or watch-and-wait

  This trial tests whether a triplet induction chemotherapy (FOLFOXIRI) before chemoradiotherapy improves response and long-term outcomes in high-risk locally advanced rectal cancer compared with a doublet induction (CAPOX/FOLFOX).

  Recruiting at 10 sites Phase 3 Catharina Ziekenhuis Eindhoven · Arnhem, Gelderland and 19 other locations · NCT07472868

• Combining chemoradiotherapy with immunotherapy for advanced rectal cancer

  This study is testing whether adding an immunotherapy drug to standard treatment can help people with advanced rectal cancer feel better and improve their quality of life.

  Recruiting at 2 sites Phase 2/3 Beijing Friendship Hospital · Beijing, Beijing Municipality and 1 other locations · NCT06312982

• Exercise to enhance chemoradiotherapy effectiveness in advanced rectal cancer patients

  This study is testing if an 11-week exercise program can help people with advanced rectal cancer get better results from their chemoradiotherapy treatment.

  Recruiting Early Phase 1 University of Hull · Cottingham, East Yorkshire · NCT06276686

• Comparing two methods for preserving organs in rectal cancer patients

  This study is testing two different ways to treat rectal cancer in patients who responded well to initial treatment, to see which method helps them keep their organs and improve their quality of life.

  Recruiting at 7 sites The Netherlands Cancer Institute · Nijmegen, Gelderland and 6 other locations · NCT05772923

• Neoadjuvant treatment for locally advanced rectal cancer using Serplulimab, CAPEOX, and Celecoxib

  This study is testing a new treatment combining an immune therapy and chemotherapy to see if it can help people with locally advanced rectal cancer before surgery.

  Recruiting Phase 2 Zhejiang University · Hangzhou, Zhejiang · NCT05731726

• Using circulating tumor DNA to guide treatment for advanced rectal cancer

  This study is testing if using a blood test to check for tumor DNA can help doctors give better treatment to people with advanced rectal cancer by personalizing their therapy based on their risk of recurrence.

  Recruiting Phase 2 Peking Union Medical College Hospital · Beijing, Beijing Municipality · NCT05601505

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.