Multicenter RCT of the Clinical Effectiveness of Oncothermia With Chemotherapy in Metastatic Pancreatic Cancer Patients
NCT ID: NCT02862015
Last Updated: 2017-10-31
Study Results
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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UNKNOWN
PHASE2
100 participants
INTERVENTIONAL
2016-08-31
2019-07-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Oncothermia
Patients with oncothermia treatment and palliative chemotherapy
Oncothermia
Oncothermia is a kind of hyperthermia treatment. It serves heat energy more selectively than conventional hyperthermia.
FOLFIRINOX or Gemcitabine based chemotherapy
As a standard palliative chemotherapy, FOLFIRINOX or Gemcitabine based chemotherapy will be treated to the patients.
Control
Patients with palliative chemotherapy only
FOLFIRINOX or Gemcitabine based chemotherapy
As a standard palliative chemotherapy, FOLFIRINOX or Gemcitabine based chemotherapy will be treated to the patients.
Interventions
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Oncothermia
Oncothermia is a kind of hyperthermia treatment. It serves heat energy more selectively than conventional hyperthermia.
FOLFIRINOX or Gemcitabine based chemotherapy
As a standard palliative chemotherapy, FOLFIRINOX or Gemcitabine based chemotherapy will be treated to the patients.
Eligibility Criteria
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Inclusion Criteria
* Patients with radiologically identified metastasis (CT or MRI)
* Patients with no history of previous chemotherapy
* Patients with ECOG score 0-2
Exclusion Criteria
* 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
* 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
20 Years
ALL
No
Sponsors
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Hospicare Inc.
UNKNOWN
Seoul National University Hospital
OTHER
Responsible Party
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Principal Investigators
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Jin-Hyeok Hwang, MD PhD
Role: STUDY_CHAIR
Seoul National University Bundang Hospital
Locations
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Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Countries
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Central Contacts
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Facility Contacts
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Jin-Hyeok Hwang, MD PhD
Role: primary
Other Identifiers
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SNUBH-IMGPB-2016-03
Identifier Type: -
Identifier Source: org_study_id