Hyperthermia, Rectal Cancer
Conditions
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.
Interventions
DEVICEElectro-hyperthermia
Addition of electro-hyperthermia to radiation
Sponsors
Yonsei Hyperthermia Study Group
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| T stage (0 - 4), N (0 - 3) stage, tumor regression grade (0 - 4) | 3 months after curative surgery by surgical pathology report | surgical pathology report |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment toxicity (grade 0 - 5) | 5 years after curative surgery by clinical assessments | clinical assessments |
Countries
South Korea
Outcome results
None listed