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

Not Applicable

• Conditions: Rectal Cancer; Hyperthermia
• Interventions: Device: Electro-hyperthermia

• Registration Number: NCT02546596
• Lead Sponsor: Yonsei Hyperthermia Study Group

Brief Summary

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

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 Timeline

• Study Start: 2014-03-25
• Study First Submitted: 2015-09-06
• Study First Submitted QC: 2015-09-08
• Study First Posted: 2015-09-11
• Primary Completion: 2019-12-15
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-12
• Last Update Posted: 2021-07-13
• Study Completion: 2022-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 76

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Electro-hyperthermia plus radiation	Electro-hyperthermia	External beam radiation 40 Gy with 20 fractions (4 weeks) Electro-hyperthermia twice a week, one hour for each session

Primary Outcome Measures

Name	Time	Method
T stage (0 - 4), N (0 - 3) stage, tumor regression grade (0 - 4)	3 months after curative surgery by surgical pathology report	surgical pathology report

Secondary Outcome Measures

Name	Time	Method
Treatment toxicity (grade 0 - 5)	5 years after curative surgery by clinical assessments	clinical assessments

Trial Locations

Locations (1)

Wonju Severance Christian Hospital; 🇰🇷 Wonju, Gangwon, Korea, Republic of