Hyperthermia With Flexible Electrode-typed 2-MHz Device During Radiotherapy for Solid Tumors

Yonsei Hyperthermia Study Group

Status: Unknown

Conditions: Solid Tumor

Treatments: Other: Hyperthermia; Radiation: Radiotherapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05282784

YURO-H8

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 19 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Hyperthermia group

Experimental group

Description:

Hyperthermia Radiotherapy

Treatment:

Radiation: Radiotherapy

Other: Hyperthermia

Control

Active Comparator group

Description:

Radiotherapy

Treatment:

Radiation: Radiotherapy