NCT02546596

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.

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
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2014

Longer than P75 for not_applicable

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

March 25, 2014

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 11, 2015

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2019

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
Last Updated

July 13, 2021

Status Verified

July 1, 2021

Enrollment Period

5.7 years

First QC Date

September 6, 2015

Last Update Submit

July 12, 2021

Conditions

Rectal CancerHyperthermia

Outcome Measures

Primary Outcomes (1)

  • T stage (0 - 4), N (0 - 3) stage, tumor regression grade (0 - 4)

    surgical pathology report

    3 months after curative surgery by surgical pathology report

Secondary Outcomes (1)

  • Treatment toxicity (grade 0 - 5)

    5 years after curative surgery by clinical assessments

Study Arms (1)

Electro-hyperthermia plus radiation

EXPERIMENTAL

External beam radiation 40 Gy with 20 fractions (4 weeks) Electro-hyperthermia twice a week, one hour for each session

Device: Electro-hyperthermia

Interventions

Electro-hyperthermiaDEVICE

Addition of electro-hyperthermia to radiation

Electro-hyperthermia plus radiation

Eligibility Criteria

Age19 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, 220-701, South Korea

Location

Related Publications (1)

  • Lee Y, Kim S, Cha H, Han JH, Choi HJ, Go E, You SH. Long-Term Feasibility of 13.56 MHz Modulated Electro-Hyperthermia-Based Preoperative Thermoradiochemotherapy in Locally Advanced Rectal Cancer. Cancers (Basel). 2022 Mar 1;14(5):1271. doi: 10.3390/cancers14051271.

    PMID: 35267579DERIVED

MeSH Terms

Conditions

Rectal NeoplasmsHyperthermia

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal DiseasesBody Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsHeat Stress DisordersWounds and Injuries

Study Officials

  • Sei Hwan You, MD

    Yonsei Hyperthermia Study Group

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2015

First Posted

September 11, 2015

Study Start

March 25, 2014

Primary Completion

December 15, 2019

Study Completion

February 28, 2022

Last Updated

July 13, 2021

Record last verified: 2021-07

Locations

KR(1)