NCT02862015

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2016

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

August 7, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 10, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

October 31, 2017

Status Verified

October 1, 2017

Enrollment Period

2.9 years

First QC Date

August 7, 2016

Last Update Submit

October 29, 2017

Conditions

Cancer, Pancreas

Outcome Measures

Primary Outcomes (1)

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

    3 months

Secondary Outcomes (3)

  • change of opioid use amount

    3 months

  • change of pain score (VAS score)

    3 months

  • Adverse effect

    3 months

Study Arms (2)

Oncothermia

EXPERIMENTAL

Patients with oncothermia treatment and palliative chemotherapy

Other: OncothermiaDrug: FOLFIRINOX or Gemcitabine based chemotherapy

Control

ACTIVE COMPARATOR

Patients with palliative chemotherapy only

Drug: FOLFIRINOX or Gemcitabine based chemotherapy

Interventions

OncothermiaOTHER

Oncothermia is a kind of hyperthermia treatment. It serves heat energy more selectively than conventional hyperthermia.

Oncothermia
FOLFIRINOX or Gemcitabine based chemotherapyDRUG

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

ControlOncothermia

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

folfirinox

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Jin-Hyeok Hwang, MD PhD

    Seoul National University Bundang Hospital

    STUDY CHAIR

Central Study Contacts

Jin-Hyeok Hwang, MD PhD

CONTACT

+82-31-787-7017woltoong@snu.ac.kr

Jaihwan Kim, MD

CONTACT

+82-31-787-7075drjaihwan@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2016

First Posted

August 10, 2016

Study Start

August 1, 2016

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

October 31, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)