Clinical trial · Interventional
The Effect of Electro-Hyperthermia in Preoperative Radiotherapy for Locally Advanced Rectal Cancer
The Effect of Electro-hyperthermia in Preoperative Radiotherapy Followed by Delayed Operation for Locally Advanced Rectal Cancer: Phase II Single Institutional Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Preoperative radiotherapy in locally advanced rectal cancer increases the possibility of complete resection and anal sphincter preservation. However, a treatment period of from 5 to 6 weeks is an obstacle of proper surgical intervention. Also, radiotherapy itself is confronting challenges for maximizing the therapeutic effect and minimizing the side effects. Electro-hyperthermia is appropriate treatment method to solve these kinds of problems. In this clinical trial, therapeutic effect of the high-frequency electro-hyperthermia is to be verified during preoperative radiotherapy for locally advanced rectal cancer. The ultimate goal is to establish a safe and effective treatment protocol.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hyperthermia | — | UNRESOLVED | — |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Electro-hyperthermia | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Electro-hyperthermia plus radiation
- description
- External beam radiation 40 Gy with 20 fractions (4 weeks) Electro-hyperthermia twice a week, one hour for each session
- interventionNames
- Device: Electro-hyperthermia
Primary outcomes (1)
- measure
- T stage (0 - 4), N (0 - 3) stage, tumor regression grade (0 - 4)
- timeFrame
- 3 months after curative surgery by surgical pathology report
- description
- surgical pathology report
Secondary outcomes (1)
- measure
- Treatment toxicity (grade 0 - 5)
- timeFrame
- 5 years after curative surgery by clinical assessments
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically-proven rectal adenocarcinoma within 15 cm from anal verge * Clinically T3-4 stage or positive lymph nodes * Performance status 0-2 * Proper function of bone marrow, kidney, and liver Exclusion Criteria: * Past disease history of rectum * Hereditary colorectal cancer * Chronic inflammatory bowel disease * Bower stenosis * Active infection * Myocardial infarction, uncontrolled arrhythmia, angina pectoris, or cardiac insufficiency within 6 months * Pregnancy, nursing * Unresected contemporary colon cancer * Thermal hypersensitivity * Too much subcutaneous fat in the abdominal and pelvic area
References
Publications (1)
- DERIVEDLee Y, Kim S, Cha H, Han JH, Choi HJ, Go E, You SH. Long-Term Feasibility of 13.56 MHz Modulated Electro-Hyperthermia-Based Preoperative Thermoradiochemotherapy in Locally Advanced Rectal Cancer. Cancers (Basel). 2022 Mar 1;14(5):1271. doi: 10.3390/cancers14051271. PMID 35267579