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

Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02546596
• Other study ID #: YURO-H1
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 25, 2014
• Est. completion date: February 28, 2022

Study information

• Verified date: July 2021
• Source: Yonsei Hyperthermia Study Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 76
• Est. completion date: February 28, 2022
• Est. primary completion date: December 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Fever
• Hyperthermia
• Rectal Cancer
• Rectal Neoplasms

Intervention

Device:
• Electro-hyperthermia
Addition of electro-hyperthermia to radiation

Locations

Country	Name	City	State
Korea, Republic of	Wonju Severance Christian Hospital	Wonju	Gangwon

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei Hyperthermia Study Group

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Treatment toxicity (grade 0 - 5)	clinical assessments	5 years after curative surgery by clinical assessments