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

NCT ID: NCT05282784

Last Updated: 2022-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-10

Study Completion Date

2022-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Solid Tumor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hyperthermia group

Hyperthermia Radiotherapy

Group Type EXPERIMENTAL

Hyperthermia

Intervention Type OTHER

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.

Radiotherapy

Intervention Type RADIATION

Patients will be treated with radiotherapy 5 times a week.

Control

Radiotherapy

Group Type ACTIVE_COMPARATOR

Radiotherapy

Intervention Type RADIATION

Patients will be treated with radiotherapy 5 times a week.

Interventions

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Hyperthermia

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.

Intervention Type OTHER

Radiotherapy

Patients will be treated with radiotherapy 5 times a week.

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medicon, Inc.

INDUSTRY

Sponsor Role collaborator

Yonsei Hyperthermia Study Group

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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YURO-H8

Identifier Type: -

Identifier Source: org_study_id

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