Solid Tumor
Conditions
Keywords
Radiotherapy, Hyperthermia
Brief summary
The main purpose of this study is to evaluate immunogenic effect of hyperthermia applied with flexible electrode-typed 2-MHz device during radiotherapy for solid tumors.
Interventions
OTHERHyperthermia
Patients will be treated with hyperthermia 2 or 3 times a week. Treatment will be performed for 1 hours per each visit. Patients will be treated with radiotherapy 5 times a week.
RADIATIONRadiotherapy
Patients will be treated with radiotherapy 5 times a week.
Sponsors
Medicon, Inc.
Yonsei Hyperthermia Study Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Solid tumor (primary, metastatic) * Eastern Cooperative Oncology Group (ECOG) score 0-3 * Ability to understand and the willingness to sign a written informed consent documents
Exclusion criteria
* Myocardial infarct, unstable angina, heart failure, uncontrolled arrhythmia within 6 months * Active infectious disease * Pregnant or probability of pregnancy during treatment * Obesity (BMI ≥35) * Immunosuppressive drug after organ transplantation * Autoimmune disease * Skin injury on treatment area
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immunogenic effect | 1 weeks after treatment | NK cell, CD4+ T cell, CD8+ T cell |
Outcome results
None listed