A Phase 3 interventional study of Hyperthermia in Locally Advanced Rectal Carcinoma, sponsored by Shih-Kai Hung. Recruiting at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2026-01-28.
Sponsored by Shih-Kai Hung · Phase 3, Interventional, and Treatment
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:
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:
This study is designed as a pivotal Phase 3, open-label, two-treatment group, multi-institute randomized control trial (1:1).
Study Population \& Allocation:
Participants with pathologically confirmed rectal adenocarcinoma who are recommended for TNT by a specialist surgeon will be included. Patients are randomly allocated (1:1) into either the Experimental Arm (TNT + mEHT combination) or the Control Arm (TNT alone).
Intervention and Device:
Modulated electro-hyperthermia (mEHT, trade name Oncotherm) will be delivered using the Oncotherm EHY-2030 device. This technique uses electromagnetic waves at 13.56 MHz and incorporates a low-frequency current wave to deliver energy selectively to the cancerous area. The Oncotherm computer system automatically adjusts the optimal frequency, introducing random resonance to heat the tumor tissue and improve the tumor microenvironment. Local hyperthermia is intended to control tumors by raising the local body temperature to 39℃-42℃.
We hypothesized that the combination of hyperthermia with other treatments (such as radiotherapy and chemotherapy) can improve treatment outcome without additional toxicity. Patients in the Experimental Arm will receive mEHT twice a week specifically during the CRT period.
2,400 studies on the registry are indexed under Rectal Neoplasms; 587 are open to participants now.
This study's planned enrollment of 126 is above the median of 65 across 1,751 interventional studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →This is the only study on the registry with Shih-Kai Hung as lead sponsor.
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Clinical staging of cT3N0 with high recurrence risk or cT3N1-2 or cT4N0-2 rectal cancer, requiring therapy, without distant ; must meet the following tumor definitions [staging system according to the 8th edition of the AJCC staging manual]:
7. 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 form for the protocol.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive standard TNT with modulated electro-hyperthermia (mEHT). This includes long-course CRT with concurrent mEHT, twice weekly, for 5-6 weeks, followed by neoadjuvant chemotherapy (4-6 months), and finally surgery. Chemoradiation therapy phase Drug: Capecitabine or Tegafur/ Uracil or Fluorouracil (5-FU) + Leucrorin (LV) concomitant with RT Procedure: Radiotherapy Total radiation dose of 45-50.4 Gy delivered in 25-28 fractions to the pelvis, and the dose of 52-56 Gy for gross tumor volumes and positive lymph nodes. Device: Oncotherm Modulated EHY-2030 Oncotherm device is working on a radiofrequency of 13.56 MHz. Treatments are administered twice weekly during the 5-6-week CRT phase. Each session lasts 60 minutes Neoadjuvant systemic therapy: 4-6 months of neoadjuvant chemotherapy using CAPEOX or mFOLFOX 6 regimens following CRT Surgery: Total mesorectal excision (TME) performed after the completion of neoadjuvant chemotherapy.
Device: Hyperthermia
Participants receive standard TNT without modulated electro-hyperthermia (mEHT). This includes long-course CRT with concurrent mEHT, twice weekly, for 5-6 weeks, followed by neoadjuvant chemotherapy (4-6 months), and finally surgery. Chemoradiation therapy phase Drug: Capecitabine or Tegafur/ Uracil or Fluorouracil (5-FU) + Leucrorin (LV) concomitant with RT Procedure: Radiotherapy Total radiation dose of 45-50.4 Gy delivered in 25-28 fractions to the pelvis, and the dose of 52-56 Gy for gross tumor volumes and positive lymph nodes. Device: Oncotherm Modulated EHY-2030 Neoadjuvant systemic therapy: 4-6 months of neoadjuvant chemotherapy using CAPEOX or mFOLFOX 6 regimens following CRT Surgery: Total mesorectal excision (TME) performed after the completion of neoadjuvant chemotherapy.
Modulated 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.
Time frame: Time Frame: 9 months from the date of randomization
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.
Time frame: 9 months from the date of randomization
Treatment Response Patterns
Using the Dworak Scale, defined as "good tumor shrinkage" with Grade 3 and Grade 4.
Time frame: 9 months
Overall Survival (OS)
OS is defined as time from randomization to the date of death due to any cause.
Time frame: 12, 36, 60 months from the date of randomization
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.
Time frame: 12, 36, 60 months from the date of randomization
Local Control Rate (LCR)
LCR is defined as the time from randomization to the date of the first documentation of local recurrence.
Time frame: Time Frame: 12, 36, 60 months from the date of randomization.
Distant Metastasis-Free Survival (DMFS)
DMFS is defined as the time from randomization to the date of the first documentation of distant metastasis.
Time frame: 12, 36, 60 months from the date of randomization
Colostomy-Free Survival (CFS)
CFS is defined as being alive without a colostomy, excluding colostomies reversed during follow-up.
Time frame: 12, 36, 60 months from the date of randomization.
Comparison of Surgery Rates
Comparison of Surgery Rates is defined as the rate of patients who receive TME between two groups after TNT.
Time frame: 12 months
Surgical Techniques
Surgical Techniques to be recorded: Total Mesorectal Excision (TME), local excision or other (specify).
Time frame: 12 months
Number of Hyperhermia
For the optimal treatment, patients in experimental arm receive hyperthermia by using Oncotherm EHY-2030 device, with a planned power output of 60 minutes. The number of treatment where this optimal output could not be reached must be recorded and reported.
Time frame: 9 months
Adverse Effects Assessment
Using CTCAE v5.0, scored 0 - 5, with higher scores indicating more severe adverse effects. The items include: radiation dermatitis, anorexia, nausea, vomiting, constipation, diarrhea, dysuria, hematuria, and fatigue. All items are planned to be evaluated at the initiation of treatment (week 1), and subsequently at the week 6, week 9, week 28, week 42, week 48, week 60, week 72, week 84, and week 96 (+/- 3 weeks is permitted).
Time frame: 2, 36, 60 months
The effect of treatment on white blood cell count
Recording total white cell counts, absolute neutrophil counts, and absolute lymphocyte counts of all patients. Blood samples are obtained at the initiation of treatment (week 1), and subsequently at the week 6, week 9, week 28, week 42, week 48, week 60, week 72, week 84, and week 96 (+/- 3 weeks is permitted).
Time frame: 2, 36, 60 months
The effect of treatment on hemoglobin level
Recording hemoglobin levels of all patients. Blood samples are obtained at the initiation of treatment (week 1), and subsequently at the week 6, week 9, week 28, week 42, week 48, week 60, week 72, week 84, and week 96 (+/- 3 weeks is permitted).
Time frame: 2, 36, 60 months
The effect of treatment on platelet count
Recording platelet counts of all patients. Blood samples are obtained at the initiation of treatment (week 1), and subsequently at the week 6, week 9, week 28, week 42, week 48, week 60, week 72, week 84, and week 96 (+/- 3 weeks is permitted).
Time frame: 2, 36, 60 months
Late Radiation Therapy Adverse Effects
Using the LENT/SOMA scoring system, evaluating symptoms such as tenesmus, mucosal loss, sphincter control, stool frequency, pain, bleeding, ulceration, stricture, etc., scored 1 - 4, with higher scores indicating worse outcomes.
Time frame: 36, 60 months
Quality of Life Analysis
Quality of Life (QoL) assessment is mandatory for all eligible patients randomized into the trial. QoL will be evaluated using the total score of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). A printed questionnaire will be administered in the clinic by a CRA or study nurse at the following time points: * Baseline (at the time of randomization, prior to treatment initiation). * The last week of neoadjuvant CRT with or without mEHT. * Nine months after the completion of the TNT course (approximately 42 weeks ± 3 weeks post-randomization).
Time frame: 12 months.
Rectal Cancer Quality of Life Analysis
Rectal Cancer Quality of Life (QoL) assessment is mandatory for all eligible patients randomized into the trial. QoL will be evaluated using the total score of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-CR29). A printed questionnaire will be administered in the clinic by a CRA or study nurse at the following time points: * Baseline (at the time of randomization, prior to treatment initiation). * The last week of neoadjuvant CRT with or without mEHT. * Nine months after the completion of the TNT course (approximately 42 weeks ± 3 weeks post-randomization).
Time frame: 12 months.
Functional Assessment Post Rectal Cancer Surgery
Using the LAR score. The QoL evaluation focus on functional outcome will be evaluated using LAR score. This assessment is mandatory for all eligible patients randomized into the trial. A printed questionnaire will be administered in the clinic by a CRA or study nurse at the following time points: * Baseline (at the time of randomization, prior to treatment initiation). * The last week of neoadjuvant CRT with or without mEHT. * Nine months after the completion of the TNT course (approximately 42 weeks ± 3 weeks post-randomization).
Time frame: 12 months
Plan to share: No
Started Sep 2025 (actual). Primary completion is estimated for Dec 2027, 27 months after the start.
Of 73 non-industry phase 3 interventional studies under Rectal Neoplasms, half reached primary completion within 76 months of starting (the median), counting those still running; a quarter within 38 and three quarters within 104. This study's planned 27 months is below that.
Counting every sponsor, half of 81 studies reached it within 59 months; a quarter within 37 and three quarters within 95.
How these figures are worked out, and which studies are left out of them.
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