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

Yonsei Hyperthermia Study Group

Status: Unknown

Conditions: Hyperthermia; Rectal Cancer

Treatments: Device: Electro-hyperthermia

Study type: Interventional

Funder types: Other

Identifiers

NCT02546596

YURO-H1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 76 patients

Sex: All

Ages: 19 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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76 participants in 1 patient group

Electro-hyperthermia plus radiation

Experimental group

Description:

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

Treatment:

Device: Electro-hyperthermia