Clinical trial NCT02546596: 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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rectal Cancer
Hyperthermia
Lead sponsor: Yonsei Hyperthermia Study Group
Sponsor class: OTHER
First posted: 2015-09-11
Enrollment: 76
Sex: ALL
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: T stage (0 - 4), N (0 - 3) stage, tumor regression grade (0 - 4)
timeFrame: 3 months after curative surgery by surgical pathology report
Secondary outcomes:
measure: Treatment toxicity (grade 0 - 5)
timeFrame: 5 years after curative surgery by clinical assessments
Other outcomes:
Locations:
city: Wonju
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
state: Gangwon
Study officials:
affiliation: Yonsei Hyperthermia Study Group
name: Sei Hwan You, MD
role: STUDY_DIRECTOR
References:
citation: 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.