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

Primary Purpose

Solid Tumor

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hyperthermia
Radiotherapy
Sponsored by
Yonsei Hyperthermia Study Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Solid Tumor focused on measuring Radiotherapy, Hyperthermia

Eligibility Criteria

19 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Hyperthermia group

    Control

    Arm Description

    Hyperthermia Radiotherapy

    Radiotherapy

    Outcomes

    Primary Outcome Measures

    Immunogenic effect
    NK cell, CD4+ T cell, CD8+ T cell

    Secondary Outcome Measures

    Full Information

    First Posted
    March 7, 2022
    Last Updated
    March 7, 2022
    Sponsor
    Yonsei Hyperthermia Study Group
    Collaborators
    Medicon, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05282784
    Brief Title
    Hyperthermia With Flexible Electrode-typed 2-MHz Device During Radiotherapy for Solid Tumors
    Official Title
    Exploratory, Open-labelled, Control Group-included, Single Institution Clinical Trial for Evaluating Immunogenic Effect of Hyperthermia Applied With Flexible Electrode-typed 2-MHz Device During Radiotherapy for Solid Tumors
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 10, 2022 (Anticipated)
    Primary Completion Date
    April 30, 2022 (Anticipated)
    Study Completion Date
    April 30, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Yonsei Hyperthermia Study Group
    Collaborators
    Medicon, Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Solid Tumor
    Keywords
    Radiotherapy, Hyperthermia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Hyperthermia group
    Arm Type
    Experimental
    Arm Description
    Hyperthermia Radiotherapy
    Arm Title
    Control
    Arm Type
    Active Comparator
    Arm Description
    Radiotherapy
    Intervention Type
    Other
    Intervention Name(s)
    Hyperthermia
    Intervention Description
    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
    Radiation
    Intervention Name(s)
    Radiotherapy
    Intervention Description
    Patients will be treated with radiotherapy 5 times a week.
    Primary Outcome Measure Information:
    Title
    Immunogenic effect
    Description
    NK cell, CD4+ T cell, CD8+ T cell
    Time Frame
    1 weeks after treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

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

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