Whole Breast RT on Prone Position in Korean Women

Phase 2

• Conditions: Breast Cancer
• Interventions: Radiation: Whole breast RT on prone position

• Registration Number: NCT02231112
• Lead Sponsor: Samsung Medical Center

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 available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2014-08-25
• Study First Submitted QC: 2014-08-31
• Study First Posted: 2014-09-04
• Status Verified: 2014-11
• Study Start: 2014-11
• Last Update Submitted: 2014-11-06
• Last Update Posted: 2014-11-07
• Primary Completion: 2015-09
• Study Completion: 2015-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 50

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prone position whole breast RT	Whole breast RT on prone position	-

Primary Outcome Measures

Name	Time	Method
Irradiated cardiac dose	At simulation, expected average of 1 week

Secondary Outcome Measures

Name	Time	Method
Irradiated lung dose	At simulation, expected average of 1 week
Skin change after RT	At 3 months after RT completion
Irradiated dose of left anterior descending artery	At simulation, expected average of 1 week
Irradiated dose of axillary lymphatic area	At simulation, expected average of 1 week
Clinical target volume (volume, homogeneity index, conformity index)	At simulation, expected average of 1 week
Breast shape after RT	At 6 months after RT completion

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of