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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hyperthermia; Rectal Cancer
• Intervention / Treatment: Device: Electro-hyperthermia

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gangwon
    • Wonju, Gangwon, Korea, Republic of, 220-701
      • WonJu Severance Christian Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Yonsei Hyperthermia Study Group
• Investigators: Study Director: Sei Hwan You, MD, Yonsei Hyperthermia Study Group

Publications and helpful links

General Publications

• Lee 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2014
• Primary Completion (Actual): December 15, 2019
• Study Completion (Anticipated): February 28, 2022

Study Registration Dates

• First Submitted: September 6, 2015
• First Submitted That Met QC Criteria: September 8, 2015
• First Posted (Estimate): September 11, 2015

Study Record Updates

• Last Update Posted (Actual): July 13, 2021
• Last Update Submitted That Met QC Criteria: July 12, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Wounds and Injuries; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Body Temperature Changes; Heat Stress Disorders; Rectal Neoplasms; Hyperthermia; Fever
• Other Study ID Numbers: YURO-H1