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Multicenter RCT of the Clinical Effectiveness of Oncothermia With Chemotherapy in Metastatic Pancreatic Cancer Patients (Oncothermia)

Primary Purpose

Cancer, Pancreas

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Oncothermia
FOLFIRINOX or Gemcitabine based chemotherapy
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer, Pancreas

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

  • Seoul National University Bundang HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Oncothermia

Control

Arm Description

Patients with oncothermia treatment and palliative chemotherapy

Patients with palliative chemotherapy only

Outcomes

Primary Outcome Measures

European Organisation for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ)-C30 score change

Secondary Outcome Measures

change of opioid use amount
change of pain score (VAS score)
Adverse effect

Full Information

First Posted
August 7, 2016
Last Updated
October 29, 2017
Sponsor
Seoul National University Hospital
Collaborators
Hospicare Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02862015
Brief Title
Multicenter RCT of the Clinical Effectiveness of Oncothermia With Chemotherapy in Metastatic Pancreatic Cancer Patients
Acronym
Oncothermia
Official Title
A Multicenter, Prospective, Randomized Clinical Trial of the Clinical Effectiveness of Oncothermia Combined With Standard Chemotherapy in Metastatic Pancreatic Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
July 2019 (Anticipated)
Study Completion Date
July 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital
Collaborators
Hospicare Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Pancreas

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Oncothermia
Arm Type
Experimental
Arm Description
Patients with oncothermia treatment and palliative chemotherapy
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Patients with palliative chemotherapy only
Intervention Type
Other
Intervention Name(s)
Oncothermia
Intervention Description
Oncothermia is a kind of hyperthermia treatment. It serves heat energy more selectively than conventional hyperthermia.
Intervention Type
Drug
Intervention Name(s)
FOLFIRINOX or Gemcitabine based chemotherapy
Intervention Description
As a standard palliative chemotherapy, FOLFIRINOX or Gemcitabine based chemotherapy will be treated to the patients.
Primary Outcome Measure Information:
Title
European Organisation for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ)-C30 score change
Time Frame
3 months
Secondary Outcome Measure Information:
Title
change of opioid use amount
Time Frame
3 months
Title
change of pain score (VAS score)
Time Frame
3 months
Title
Adverse effect
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jin-Hyeok Hwang, MD PhD
Phone
+82-31-787-7017
Email
woltoong@snu.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Jaihwan Kim, MD
Phone
+82-31-787-7075
Email
drjaihwan@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin-Hyeok Hwang, MD PhD
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin-Hyeok Hwang, MD PhD
Phone
+82-31-787-7017
First Name & Middle Initial & Last Name & Degree
Jin-Hyeok Hwang, MD PhD
First Name & Middle Initial & Last Name & Degree
Jaihwan Kim, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Multicenter RCT of the Clinical Effectiveness of Oncothermia With Chemotherapy in Metastatic Pancreatic Cancer Patients

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