Whole Breast RT on Prone Position in Korean Women

November 6, 2014 updated by: Doo Ho Choi, Samsung Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 135-710
        • Recruiting
        • Samsung Medical Center
        • Contact:
        • Principal Investigator:
          • Doo Ho Choi, M.D., Ph.D.
        • Sub-Investigator:
          • Won Park, M.D., Ph.D.
        • Sub-Investigator:
          • Yunsun Chung, PhD
        • Sub-Investigator:
          • Seung Jae Huh, M.D., Ph.D.
        • Sub-Investigator:
          • Jeong Il Yu, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prone position whole breast RT
Radiation: Whole breast RT on prone position

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Anticipated)

September 1, 2015

Study Completion (Anticipated)

September 1, 2015

Study Registration Dates

First Submitted

August 25, 2014

First Submitted That Met QC Criteria

August 31, 2014

First Posted (Estimate)

September 4, 2014

Study Record Updates

Last Update Posted (Estimate)

November 7, 2014

Last Update Submitted That Met QC Criteria

November 6, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-06-138-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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