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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

Tracking Information
First Submitted Date  ICMJE September 6, 2015
First Posted Date  ICMJE September 11, 2015
Last Update Posted Date January 16, 2018
Study Start Date  ICMJE April 2014
Estimated Primary Completion Date February 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 12, 2018)
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
Original Primary Outcome Measures  ICMJE
 (submitted: September 8, 2015)
T stage (0 - 4), N (0 - 3) stage, tumor regression grade (0 - 4) [ Time Frame: 3 months after curative surgery ]
Change History Complete list of historical versions of study NCT02546596 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 12, 2018)
Treatment toxicity (grade 0 - 5) [ Time Frame: 5 years after curative surgery by clinical assessments ]
clinical assessments
Original Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2015)
  • Survival (months) [ Time Frame: 5 years after curative surgery ]
  • Treatment toxicity (grade 0 - 5) [ Time Frame: 5 years after curative surgery ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Electro-Hyperthermia in Preoperative Radiotherapy for Locally Advanced Rectal Cancer
Official Title  ICMJE The Effect of Electro-hyperthermia in Preoperative Radiotherapy Followed by Delayed Operation for Locally Advanced Rectal Cancer: Phase II Single Institutional Study
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Rectal Cancer
  • Hyperthermia
Intervention  ICMJE Device: Electro-hyperthermia
Addition of electro-hyperthermia to radiation
Study Arms  ICMJE 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
Intervention: Device: Electro-hyperthermia
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 8, 2015)
72
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2022
Estimated Primary Completion Date February 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sei Hwan You, MD 82-33-741-1518 ys3259@yonsei.ac.kr
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02546596
Other Study ID Numbers  ICMJE YURO-H1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yonsei Hyperthermia Study Group
Study Sponsor  ICMJE Yonsei Hyperthermia Study Group
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Sei Hwan You, MD Yonsei Hyperthermia Study Group
PRS Account Yonsei Hyperthermia Study Group
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP