The Effect of Electro-Hyperthermia in Preoperative Radiot... | NCT02546596

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

NCT02546596

Sponsor

Yonsei Hyperthermia Study Group

Status

Unknown status

Last Update Posted

Jul 13, 2021Actual

Enrollment

76Actual

Phase

Not Applicable

Conditions

Rectal Cancer
Hyperthermia

Interventions

Electro-hyperthermia

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 25, 2014Actual

Primary Completion Date

Dec 15, 2019Actual

Completion Date

Feb 28, 2022Estimated

First Submitted Date

Sep 6, 2015

First Submission Date that Met QC Criteria

Sep 8, 2015

First Posted Date

Sep 11, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 12, 2021

Last Update Posted Date

Jul 13, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

76Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Electro-hyperthermia	Device	Addition of electro-hyperthermia to radiation	Electro-hyperthermia plus radiation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Treatment toxicity (grade 0 - 5)	clinical assessments	5 years after curative surgery by clinical assessments

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sei Hwan You, MD	Yonsei Hyperthermia Study Group	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Wonju Severance Christian Hospital		Wŏnju	Gangwon-do	220-701	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35267579	Derived	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.

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms