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Whole Breast RT on Prone Position in Korean Women

Primary Purpose

Breast Cancer

Status

Unknown status

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Whole breast RT on prone position

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Korean, Left side

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Samsung Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Prone position whole breast RT

Arm Description

Outcomes

Primary Outcome Measures

Irradiated cardiac dose

Secondary Outcome Measures

Irradiated dose of left anterior descending artery

Irradiated lung dose

Clinical target volume (volume, homogeneity index, conformity index)

Irradiated dose of axillary lymphatic area

Skin change after RT

Breast shape after RT

Full Information

NCT ID

NCT02231112

First Posted

August 25, 2014

Last Updated

November 6, 2014

Sponsor

Samsung Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT02231112

Brief Title

Whole Breast RT on Prone Position in Korean Women

Official Title

Feasibility of Prone Position in Postoperative Whole Breast Radiation Therapy in Korean Breast Cancer Patient

Study Type

Interventional

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Unknown status

Study Start Date

November 2014 (undefined)

Primary Completion Date

September 2015 (Anticipated)

Study Completion Date

September 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Samsung Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

Korean, Left side

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Prone position whole breast RT

Arm Type

Experimental

Intervention Type

Radiation

Intervention Name(s)

Whole breast RT on prone position

Primary Outcome Measure Information:

Title

Irradiated cardiac dose

Time Frame

At simulation, expected average of 1 week

Secondary Outcome Measure Information:

Title

Irradiated dose of left anterior descending artery

Time Frame

At simulation, expected average of 1 week

Title

Irradiated lung dose

Time Frame

At simulation, expected average of 1 week

Title

Clinical target volume (volume, homogeneity index, conformity index)

Time Frame

At simulation, expected average of 1 week

Title

Irradiated dose of axillary lymphatic area

Time Frame

At simulation, expected average of 1 week

Title

Skin change after RT

Time Frame

At 3 months after RT completion

Title

Breast shape after RT

Time Frame

At 6 months after RT completion

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Doo Ho Choi, M.D., Ph.D.

Phone

82-2-3410-2612

doho.choi@samsung.com

Facility Information:

Facility Name

Samsung Medical Center

City

Seoul

ZIP/Postal Code

135-710

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact: