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Trial record 35 of 131 for:    Pancreatic Cancer | ( Map: South Korea )

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

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ClinicalTrials.gov Identifier: NCT02862015
Recruitment Status : Recruiting
First Posted : August 10, 2016
Last Update Posted : October 31, 2017
Sponsor:
Collaborator:
Hospicare Inc.
Information provided by (Responsible Party):
Seoul National University Hospital

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.


Condition or disease Intervention/treatment Phase
Cancer, Pancreas Other: Oncothermia Drug: FOLFIRINOX or Gemcitabine based chemotherapy Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Prospective, Randomized Clinical Trial of the Clinical Effectiveness of Oncothermia Combined With Standard Chemotherapy in Metastatic Pancreatic Cancer Patients
Study Start Date : August 2016
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Gemcitabine

Arm Intervention/treatment
Experimental: Oncothermia
Patients with oncothermia treatment and palliative chemotherapy
Other: Oncothermia
Oncothermia is a kind of hyperthermia treatment. It serves heat energy more selectively than conventional hyperthermia.

Drug: FOLFIRINOX or Gemcitabine based chemotherapy
As a standard palliative chemotherapy, FOLFIRINOX or Gemcitabine based chemotherapy will be treated to the patients.

Active Comparator: Control
Patients with palliative chemotherapy only
Drug: FOLFIRINOX or Gemcitabine based chemotherapy
As a standard palliative chemotherapy, FOLFIRINOX or Gemcitabine based chemotherapy will be treated to the patients.




Primary Outcome Measures :
  1. European Organisation for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ)-C30 score change [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. change of opioid use amount [ Time Frame: 3 months ]
  2. change of pain score (VAS score) [ Time Frame: 3 months ]
  3. Adverse effect [ Time Frame: 3 months ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02862015


Contacts
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Contact: Jin-Hyeok Hwang, MD PhD +82-31-787-7017 woltoong@snu.ac.kr
Contact: Jaihwan Kim, MD +82-31-787-7075 drjaihwan@gmail.com

Locations
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Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam, Gyeonggi-do, Korea, Republic of, 463-707
Contact: Jin-Hyeok Hwang, MD PhD    +82-31-787-7017      
Principal Investigator: Jin-Hyeok Hwang, MD PhD         
Sub-Investigator: Jaihwan Kim, MD         
Sponsors and Collaborators
Seoul National University Hospital
Hospicare Inc.
Investigators
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Study Chair: Jin-Hyeok Hwang, MD PhD Seoul National University Bundang Hospital

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Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02862015     History of Changes
Other Study ID Numbers: SNUBH-IMGPB-2016-03
First Posted: August 10, 2016    Key Record Dates
Last Update Posted: October 31, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Pancreatic Diseases
Digestive System Diseases
Endocrine System Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs