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The Effect of Electro-Hyperthermia in Preoperative Radiotherapy for Locally Advanced Rectal Cancer

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ClinicalTrials.gov Identifier: NCT02546596
Recruitment Status : Recruiting
First Posted : September 11, 2015
Last Update Posted : January 16, 2018
Sponsor:
Information provided by (Responsible Party):
Yonsei Hyperthermia Study Group

Brief Summary:
Preoperative radiotherapy in locally advanced rectal cancer increases the possibility of complete resection and anal sphincter preservation. However, a treatment period of from 5 to 6 weeks is an obstacle of proper surgical intervention. Also, radiotherapy itself is confronting challenges for maximizing the therapeutic effect and minimizing the side effects. Electro-hyperthermia is appropriate treatment method to solve these kinds of problems. In this clinical trial, therapeutic effect of the high-frequency electro-hyperthermia is to be verified during preoperative radiotherapy for locally advanced rectal cancer. The ultimate goal is to establish a safe and effective treatment protocol.

Condition or disease Intervention/treatment Phase
Rectal Cancer Hyperthermia Device: Electro-hyperthermia Phase 2

Detailed Description:
Preoperative radiotherapy in locally advanced rectal cancer increases the possibility of complete resection and anal sphincter preservation. However, a treatment period of from 5 to 6 weeks is an obstacle of proper surgical intervention. Also, radiotherapy itself is confronting challenges for maximizing the therapeutic effect and minimizing the side effects. Electro-hyperthermia is appropriate treatment method to solve these kinds of problems. In this clinical trial, therapeutic effect of the high-frequency electro-hyperthermia is to be verified during preoperative radiotherapy for locally advanced rectal cancer. The endpoint of the trial is treatment safety and non-inferiority of tumor regression to conventional schedule of preoperative radiotherapy.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Electro-hyperthermia in Preoperative Radiotherapy Followed by Delayed Operation for Locally Advanced Rectal Cancer: Phase II Single Institutional Study
Study Start Date : April 2014
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever

Arm Intervention/treatment
Experimental: Electro-hyperthermia plus radiation
External beam radiation 40 Gy with 20 fractions (4 weeks) Electro-hyperthermia twice a week, one hour for each session
Device: Electro-hyperthermia
Addition of electro-hyperthermia to radiation




Primary Outcome Measures :
  1. T stage (0 - 4), N (0 - 3) stage, tumor regression grade (0 - 4) [ Time Frame: 3 months after curative surgery by surgical pathology report ]
    surgical pathology report


Secondary Outcome Measures :
  1. Treatment toxicity (grade 0 - 5) [ Time Frame: 5 years after curative surgery by clinical assessments ]
    clinical assessments



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pathologically-proven rectal adenocarcinoma within 15 cm from anal verge
  • Clinically T3-4 stage or positive lymph nodes
  • Performance status 0-2
  • Proper function of bone marrow, kidney, and liver

Exclusion Criteria:

  • Past disease history of rectum
  • Hereditary colorectal cancer
  • Chronic inflammatory bowel disease
  • Bower stenosis
  • Active infection
  • Myocardial infarction, uncontrolled arrhythmia, angina pectoris, or cardiac insufficiency within 6 months
  • Pregnancy, nursing
  • Unresected contemporary colon cancer
  • Thermal hypersensitivity
  • Too much subcutaneous fat in the abdominal and pelvic area

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): NCT02546596


Contacts
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Contact: Sei Hwan You, MD 82-33-741-1518 ys3259@yonsei.ac.kr

Locations
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Korea, Republic of
Wonju Severance Christian Hospital Recruiting
Wonju, Gangwon, Korea, Republic of, 220-701
Contact: Sei Hwan You, MD    82-33-741-1518    ys3259@yonsei.ac.kr   
Sponsors and Collaborators
Yonsei Hyperthermia Study Group
Investigators
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Study Director: Sei Hwan You, MD Yonsei Hyperthermia Study Group

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Responsible Party: Yonsei Hyperthermia Study Group
ClinicalTrials.gov Identifier: NCT02546596     History of Changes
Other Study ID Numbers: YURO-H1
First Posted: September 11, 2015    Key Record Dates
Last Update Posted: January 16, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
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Rectal Neoplasms
Fever
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Body Temperature Changes
Signs and Symptoms