Whole Breast RT on Prone Position in Korean Women
Feasibility of Prone Position in Postoperative Whole Breast Radiation Therapy in Korean Breast Cancer Patient
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 breast-cancer
Started Nov 2014
Shorter than P25 for phase_2 breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 25, 2014
CompletedFirst Posted
Study publicly available on registry
September 4, 2014
CompletedStudy Start
First participant enrolled
November 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedNovember 7, 2014
November 1, 2014
10 months
August 25, 2014
November 6, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Irradiated cardiac dose
At simulation, expected average of 1 week
Secondary Outcomes (6)
Irradiated dose of left anterior descending artery
At simulation, expected average of 1 week
Irradiated lung dose
At simulation, expected average of 1 week
Clinical target volume (volume, homogeneity index, conformity index)
At simulation, expected average of 1 week
Irradiated dose of axillary lymphatic area
At simulation, expected average of 1 week
Skin change after RT
At 3 months after RT completion
- +1 more secondary outcomes
Study Arms (1)
Prone position whole breast RT
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Pathologically confirmed left breast cancer
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Samsung Medical Center
Seoul, 135-710, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 25, 2014
First Posted
September 4, 2014
Study Start
November 1, 2014
Primary Completion
September 1, 2015
Study Completion
September 1, 2015
Last Updated
November 7, 2014
Record last verified: 2014-11