Solid TumorNCT05282784
Hyperthermia With Flexible Electrode-typed 2-MHz Device During Radiotherapy for Solid Tumors
A study testing Hyperthermia and Radiotherapy in people with Solid Tumor, run by Yonsei Hyperthermia Study Group.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Solid Tumor
- What is being tested?
- Hyperthermia and Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 10 Mar 2022to 30 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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
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.
- Conditions
- Solid Tumor
- Being tested
- Hyperthermia, Radiotherapy
- Keywords
- Radiotherapy, Hyperthermia
- Medical subject headings
- Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HyperthermiaOther
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.
RadiotherapyRadiation
Patients will be treated with radiotherapy 5 times a week.
| Study group | Role | What they receive |
|---|---|---|
| Hyperthermia group | Experimental | Hyperthermia Radiotherapy Receives: Other: Hyperthermia; Radiation: Radiotherapy |
| Control | Active comparator | Radiotherapy Receives: Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenic effect
NK cell, CD4+ T cell, CD8+ T cell
Measured: 1 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start10 Mar 2022 (estimated)
- Primary completion30 Apr 2022 (estimated)
- Study completion30 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei Hyperthermia Study Group
- Sponsor type
- University, hospital or other
- Collaborators
- Medicon, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05282784
- Sponsor's protocol ID
- YURO-H8
- Status last verified
- Mar 2022
- First submitted
- 7 Mar 2022
- Last updated
- 16 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05282784
- Acronym / sponsor ID
- YURO-H8
- Conditions
- Solid Tumor
- Keywords
- Radiotherapy, Hyperthermia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Yonsei Hyperthermia Study GroupUniversity, hospital or other
- Collaborators
- Medicon, Inc.
- Study start
- 10 Mar 2022 (estimated)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 16 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyperthermia group | Experimental | Other: Hyperthermia, Radiation: RadiotherapyHyperthermia Radiotherapy |
| Control | Active comparator | Radiation: RadiotherapyRadiotherapy |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HyperthermiaPatients 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. | Other | Hyperthermia group |
| RadiotherapyPatients will be treated with radiotherapy 5 times a week. | Radiation | Control, Hyperthermia group |
Primary outcome
Immunogenic effect
Time frame: 1 weeks after treatment
NK cell, CD4+ T cell, CD8+ T cell
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
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A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperthermia and Radiotherapy in people with Solid Tumor, run by Yonsei Hyperthermia Study Group.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunogenic effect (time frame: 1 weeks after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2022.