Whole Breast RT on Prone Position in Korean Women | NCT02231112

Studies
Whole Breast RT on Prone Position in Korean Women

NCT02231112

Sponsor

Samsung Medical Center

Status

Unknown status

Last Update Posted

Nov 7, 2014Estimated

Enrollment

50Estimated

Phase

Phase 2

Conditions

Breast Cancer

Interventions

Whole breast RT on prone position

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

Nov 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2014

Primary Completion Date

Sep 2015Estimated

Completion Date

Sep 2015Estimated

First Submitted Date

Aug 25, 2014

First Submission Date that Met QC Criteria

Aug 31, 2014

First Posted Date

Sep 4, 2014Estimated

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

Nov 6, 2014

Last Update Posted Date

Nov 7, 2014Estimated

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

It is well known fact that postoperative whole breast radiation therapy (RT) in left breast cancer patient can cause cardiac problem according to the exposed dose. In the several studies in other countries, it was repeatedly showed that RT on prone position can reduce cardiac exposed RT dose in left breast cancer. However, the effectiveness of prone position in RT is not studied in the Korean women have relatively small breast. The investigators planned this study to evaluate the real efficacy of prone position in Korean breast cancer treated with RT.

Detailed Description

Not provided

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

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Prone position whole breast RT	Experimental		Radiation: Whole breast RT on prone position

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Whole breast RT on prone position	Radiation		Prone position whole breast RT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Irradiated cardiac dose		At simulation, expected average of 1 week

Secondary Outcomes

Measure	Description	Time Frame
Irradiated dose of left anterior descending artery		At simulation, expected average of 1 week
Irradiated lung dose		At simulation, expected average of 1 week

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pathologically confirmed left breast cancer
20 or older age
less than 70 years old
after curative resection
Eastern Cooperative Oncology Group performance status 0 to 1
Informed consent to this study
Consent to contraception for 6 months after RT completion

Exclusion Criteria:

Male breast cancer
Combined distant metastasis
Status of pregnant or brest feeding
Previous RT history of chest or neck area
Indication of supraclavicular RT
Not indicated postoperative whole breast RT

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Doo Ho Choi, M.D., Ph.D.	Contact	82-2-3410-2612		doho.choi@samsung.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Samsung Medical Center	Recruiting	Seoul		135-710	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided