Cancer, PancreasPhase 2OncothermiaNCT02862015
Multicenter RCT of the Clinical Effectiveness of Oncothermia With Chemotherapy in Metastatic Pancreatic Cancer Patients
A Phase 2 study testing Oncothermia and FOLFIRINOX or Gemcitabine based chemotherapy in people with Cancer, Pancreas, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Patients with pancreatic cancer often suffer from pain. Because of such a pain, their quality of life have seriously deteriorated. There have been a few studies that showed an effect for pain control by hyperthermia (heating the patient's body). However, there are several limitations in conventional hyperthermia. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Cancer, Pancreas
- What is being tested?
- Oncothermia and FOLFIRINOX or Gemcitabine based chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2016to Jul 2019
- Phase
- Phase 2
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with pathologically confirmed pancreatic adenocarcinoma
- Patients with radiologically identified metastasis (CT or MRI)
- Patients with no history of previous chemotherapy
- Patients with ECOG score 0-2
Who cannot join
- Patients who have an experience of hyperthermia treatment
- Patients who have a difficulty of sensing heat
- Patients who have a skin graft or breast reconstruction surgery
- Patients who have a cardiac pacemaker or an implanted metal
- Pregnant or breast feeding women
- Patients with uncontrolled infection, diabetes, hypertension, ischemic heart disease, myocardial infarct within 6 months
Show all 9Show fewer
- Patients who were treated with unproved drugs within 30 days
- Patients who have a serious disease which can affect the person's safety
- Patients who do not consent to the study
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
Jin-Hyeok Hwang, MD PhD, +82-31-787-7017
Jin-Hyeok Hwang, MD PhD
About this study
Official title: A Multicenter, Prospective, Randomized Clinical Trial of the Clinical Effectiveness of Oncothermia Combined With Standard Chemotherapy in Metastatic Pancreatic Cancer Patients
Patients with pancreatic cancer often suffer from pain. Because of such a pain, their quality of life have seriously deteriorated. There have been a few studies that showed an effect for pain control by hyperthermia (heating the patient's body). However, there are several limitations in conventional hyperthermia.
In a previous pilot study (NCT02150135), we found the improvement of quality of life, function, and symptom.
From this background, the investigators tried to show the effect of "Oncothermia" with conventional chemotherapy for pain control, increasing quality of life, and anti-tumor treatment.
- Conditions
- Cancer, Pancreas
- Being tested
- Oncothermia, FOLFIRINOX or Gemcitabine based chemotherapy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OncothermiaOther
Oncothermia is a kind of hyperthermia treatment. It serves heat energy more selectively than conventional hyperthermia.
FOLFIRINOX or Gemcitabine based chemotherapyDrug
As a standard palliative chemotherapy, FOLFIRINOX or Gemcitabine based chemotherapy will be treated to the patients.
| Study group | Role | What they receive |
|---|---|---|
| Oncothermia | Experimental | Patients with oncothermia treatment and palliative chemotherapy Receives: Other: Oncothermia; Drug: FOLFIRINOX or Gemcitabine based chemotherapy |
| Control | Active comparator | Patients with palliative chemotherapy only Receives: Drug: FOLFIRINOX or Gemcitabine based chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
European Organisation for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ)-C30 score change
Measured: 3 months
Secondary outcomes (3)
change of opioid use amount
Measured: 3 months
change of pain score (VAS score)
Measured: 3 months
Adverse effect
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionJul 2019 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer, PancreasStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hospicare Inc.
- Responsible party
- Sponsor
- Investigators
- Jin-Hyeok Hwang, MD PhD, Study chair, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02862015
- Sponsor's protocol ID
- SNUBH-IMGPB-2016-03
- Acronym
- Oncothermia
- Status last verified
- Oct 2017
- First submitted
- 7 Aug 2016
- Last updated
- 31 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Randomized Clinical Trial of the Clinical Effectiveness of Oncothermia Combined With Standard Chemotherapy in Metastatic Pancreatic Cancer Patients
- ClinicalTrials.gov ID
- NCT02862015
- Acronym / sponsor ID
- Oncothermia / SNUBH-IMGPB-2016-03
- Conditions
- Cancer, Pancreas
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Hospicare Inc.
- Study start
- Aug 2016
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 10 Aug 2016 (estimated)
- 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.
Patients with pancreatic cancer often suffer from pain. Because of such a pain, their quality of life have seriously deteriorated. There have been a few studies that showed an effect for pain control by hyperthermia (heating the patient's body). However, there are several limitations in conventional hyperthermia.
In a previous pilot study (NCT02150135), we found the improvement of quality of life, function, and symptom.
From this background, the investigators tried to show the effect of "Oncothermia" with conventional chemotherapy for pain control, increasing quality of life, and anti-tumor treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oncothermia | Experimental | Other: Oncothermia, Drug: FOLFIRINOX or Gemcitabine based chemotherapyPatients with oncothermia treatment and palliative chemotherapy |
| Control | Active comparator | Drug: FOLFIRINOX or Gemcitabine based chemotherapyPatients with palliative chemotherapy only |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with pathologically confirmed pancreatic adenocarcinoma
- Patients with radiologically identified metastasis (CT or MRI)
- Patients with no history of previous chemotherapy
- Patients with ECOG score 0-2
Key exclusion criteria (9 listed)
- Patients who have an experience of hyperthermia treatment
- Patients who have a difficulty of sensing heat
- Patients who have a skin graft or breast reconstruction surgery
- Patients who have a cardiac pacemaker or an implanted metal
- Pregnant or breast feeding women
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 |
|---|---|---|
| OncothermiaOncothermia is a kind of hyperthermia treatment. It serves heat energy more selectively than conventional hyperthermia. | Other | Oncothermia |
| FOLFIRINOX or Gemcitabine based chemotherapyAs a standard palliative chemotherapy, FOLFIRINOX or Gemcitabine based chemotherapy will be treated to the patients. | Drug | Control, Oncothermia |
Primary outcome
European Organisation for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ)-C30 score change
Time frame: 3 months
3 secondary outcomes
change of opioid use amount
Time frame: 3 months
change of pain score (VAS score)
Time frame: 3 months
Adverse effect
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2017.
- Individual participant dataSharing planned: No
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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.
Jin-Hyeok Hwang, MD PhD study chair
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oncothermia and FOLFIRINOX or Gemcitabine based chemotherapy in people with Cancer, Pancreas, run by Seoul National University Hospital at 1 site in South Korea.
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 4 inclusion and 9 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 31 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Jin-Hyeok Hwang, MD PhD (+82-31-787-7017, woltoong@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
European Organisation for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ)-C30 score change (time frame: 3 months). 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 31 Oct 2017.