The Effect of Electro-Hyperthermia in Preoperative Radiotherapy for Locally Advanced Rectal Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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 endpoint of the trial is treatment safety and non-inferiority of tumor regression to conventional schedule of preoperative radiotherapy.

Official Title
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The Effect of Electro-hyperthermia in Preoperative Radiotherapy Followed by Delayed Operation for Locally Advanced Rectal Cancer: Phase II Single Institutional Study

Conditions
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Rectal Cancer, Hyperthermia

Intervention / Treatment
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* Device: Electro-hyperthermia


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electro-hyperthermia plus radiation<br>External beam radiation 40 Gy with 20 fractions (4 weeks) Electro-hyperthermia twice a week, one hour for each session | Device: Electro-hyperthermia<br>* Addition of electro-hyperthermia to radiation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| T stage (0 - 4), N (0 - 3) stage, tumor regression grade (0 - 4) | surgical pathology report | 3 months after curative surgery by surgical pathology report | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment toxicity (grade 0 - 5) | clinical assessments | 5 years after curative surgery by clinical assessments |