Spots Global Cancer Trial Database for The Effect of Electro-Hyperthermia in Preoperative Radiotherapy for Locally Advanced Rectal Cancer
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Trial Identification
Brief Title: The Effect of Electro-Hyperthermia in Preoperative Radiotherapy for Locally Advanced Rectal Cancer
Official Title: The Effect of Electro-hyperthermia in Preoperative Radiotherapy Followed by Delayed Operation for Locally Advanced Rectal Cancer: Phase II Single Institutional Study
Study ID: NCT02546596
Interventions
Study Description
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.
Keywords
Eligibility
Minimum Age: 19 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Wonju Severance Christian Hospital, Wonju, Gangwon, Korea, Republic of
Contact Details
Name: Sei Hwan You, MD
Affiliation: Yonsei Hyperthermia Study Group
Role: STUDY_DIRECTOR
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