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

NCT ID: NCT02546596

Last Updated: 2021-07-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-25
• Study Completion Date: 2022-02-28

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.

Conditions

Rectal Cancer; Hyperthermia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Electro-hyperthermia plus radiation

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

Group Type: EXPERIMENTAL

Electro-hyperthermia

Intervention Type: DEVICE

Addition of electro-hyperthermia to radiation

Interventions

Electro-hyperthermia

Addition of electro-hyperthermia to radiation

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei Hyperthermia Study Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sei Hwan You, MD

Role: STUDY_DIRECTOR

Yonsei Hyperthermia Study Group

Locations

Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 35267579 (View on PubMed)

Other Identifiers

YURO-H1

Identifier Type: -

Identifier Source: org_study_id