Trial | NCT02862015  Report issue

Title

Multicenter RCT of the Clinical Effectiveness of Oncothermia With Chemotherapy in Metastatic Pancreatic Cancer Patients
A Multicenter, Prospective, Randomized Clinical Trial of the Clinical Effectiveness of Oncothermia Combined With Standard Chemotherapy in Metastatic Pancreatic Cancer Patients

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    100
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 Started
Aug 31
2016
Primary Completion
Jul 31
2019
Anticipated
Study Completion
Jul 31
2019
Anticipated
Last Update
Oct 31
2017

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.

Oncothermia Experimental

Patients with oncothermia treatment and palliative chemotherapy

Control Active Comparator

Patients with palliative chemotherapy only

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
No Results Posted