Organ Preservation in Patients With Rectal Adenocarcinoma Treated With Total Neoadjuvant Therapy.
Julio Garcia-Aguilar, Sujata Patil, Marc J Gollub...
https://pubmed.ncbi.nlm.nih.gov/35483010Actively Recruiting
Phase 3
Age: 20Years +
All Genders
ID07372300
The Efficacy of Combination of Modulated Electro-Hyperthermia (mEHT) in the Multimodality Management of Locally Advanced Rectal Cancer: A Multicenter Phase 3 Randomized Control Trial
Led by Shih-Kai Hung · Updated on 2026-01-28
126
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
S
Shih-Kai Hung
Lead Sponsor
D
Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether adding modulated electro-hyperthermia (mEHT) to Total Neoadjuvant Therapy (TNT) can improve tumor down-staging and pathological response in adults aged 20 years and above with locally advanced rectal adenocarcinoma. This Phase 3, open-label study aims to compare TNT alone versus TNT combined with mEHT to see if the addition enhances tumor regression and long-term outcomes such as disease-free survival. Participants are randomly assigned to one of two groups: the experimental group receives TNT plus mEHT delivered by the Oncotherm EHY-2030 device twice weekly during the 5-6 week chemoradiotherapy (CRT) phase, while the control group receives TNT alone. TNT includes 5-6 weeks of chemoradiotherapy followed by 4-6 months of neoadjuvant chemotherapy, and finally surgery called total mesorectal excision (TME). Throughout the study, participants will undergo chemoradiotherapy with concurrent medications and radiation, followed by chemotherapy regimens CAPEOX or mFOLFOX 6. Researchers will assess tumor down-staging rates at 9 months, pathological complete response, survival outcomes up to 60 months, and quality of life. Safety and blood cell counts will be monitored at several intervals. The total involvement includes treatment, follow-up assessments, and surgery to evaluate the effectiveness and safety of the combined treatments.
CONDITIONS
Brief Title
Modulated Electro-Hyperthermia in Combination With Multimodal Therapy for Locally Advanced Rectal Cancer
Who Can Participate
Age: 20Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 20 years and above
- Any gender
- Initial pathological diagnosis of rectal adenocarcinoma
- Expected survival of at least six months
- Clinical staging of cT3N0 with high recurrence risk, cT3N1-2, or cT4N0-2 rectal cancer without distant metastasis
- ECOG performance status between 0 and 2
- Suitable health condition for standard treatment including long-course radiotherapy and chemotherapy
- Willingness to participate and signed informed consent
You will not qualify if you...
- Active infection or severe disease unsuitable for trial treatments
- Known HIV infection
- Untreated thyroid disease
- Active Crohn's disease or ulcerative colitis
- Other systemic autoimmune diseases
- Physical or mental disorders preventing understanding or compliance with trial requirements
- Known allergic reaction to trial medications
- Pregnant or breastfeeding women
- Substance or alcohol dependence within six months before screening
- Inability to comply with treatment, assessments, or follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Approximately 5 to 6 weeks of CRT followed by 4 to 6 months of chemotherapy
Participants receive total neoadjuvant therapy (TNT), which includes long-course chemoradiation therapy (CRT) followed by neoadjuvant chemotherapy, with or without modulated electro-hyperthermia (mEHT) depending on randomization.
Twice weekly visits during CRT for mEHT sessions plus regular visits for chemotherapy and radiotherapy
Surgery
Duration - Single surgical procedure following chemotherapy completion
Participants undergo total mesorectal excision (TME) surgery after completing neoadjuvant chemotherapy.
1 visit for surgery
Follow-up
Duration - Up to 60 months from randomization
Participants are monitored for treatment response, adverse effects, and survival outcomes after surgery.
Periodic follow-up visits over several years
Trial Site Locations
Total: 1 location
1
Dalin Tzu Chi Hospital
Chiayi City, Dalin Township, Taiwan, 600401
Actively Recruiting
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Research Team
P
Pei-Yu Hsu, Master
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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