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Prone Whole-Breast RadiationTherapy Versus Supine Whole-Breast Radiation Therapy Imaging

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ClinicalTrials.gov Identifier: NCT03037723
Recruitment Status : Unknown
Verified January 2017 by Anna Shapiro, State University of New York - Upstate Medical University.
Recruitment status was:  Recruiting
First Posted : January 31, 2017
Last Update Posted : January 31, 2017
Sponsor:
Information provided by (Responsible Party):
Anna Shapiro, State University of New York - Upstate Medical University

Brief Summary:

Radiation therapy to the breast has remained a standard practice for breast conserving therapy. Because of the location of the heart and lungs when patients are positioned face-up, whole breast radiation therapy has been reported to increase the risk of damage to the heart a few years after treatment until at least 20 years after exposure, and may affect cardiovascular mortality. Also, patients receiving whole breast radiation therapy are at an increased risk for development of secondary lung malignancies. Recent studies have demonstrated a significant reduction in dose to the heart and lungs when treated in the face-down position. Similarly, correcting for the movement of breathing (respiratory gating) in the face-up position has also become an available option for reducing unwanted dose to the heart and lungs, particularly in left sided breast cancers. No study to date has compared these newer organ-sparing techniques head-to-head for early stage breast cancer.

It is institutional policy to perform CT simulation in left-sided breast cancer patients with and without the respiratory gating (this is one CT scan), in the face-up position. It is also standard of care to perform the face-down CT simulation in large breasted women. Both of these simulations are meant to reduce the exposure of the heart and lungs to radiation.

In this study, all left-sided breast cancer patients that consent will receive face-up CT simulation with and without gating AND face-down CT simulation, regardless of breast size; thus, each patient is their own control.

The treating physician will determine which of the two simulations, if any, offers better protection to each patients' heart and lungs. Two dosimetrists will be required to independently verify planned dosimetry with all treatment setups. Treatment will be planned in standard fashion using the best of the two plans.


Condition or disease Intervention/treatment Phase
Breast Cancer, Respiratory Gating, Prone Other: CT simulation Not Applicable

Detailed Description:

Radiation therapy to the breast has remained a standard practice for breast conserving therapy. Because of the location of the heart and lungs when patients are positioned face-up, whole breast radiation therapy has been reported to increase the risk of damage to the heart a few years after treatment until at least 20 years after exposure, and may affect cardiovascular mortality. Also, patients receiving whole breast radiation therapy are at an increased risk for development of secondary lung malignancies. Recent studies have demonstrated a significant reduction in dose to the heart and lungs when treated in the face-down position. Similarly, correcting for the movement of breathing (respiratory gating) in the face-up position has also become an available option for reducing unwanted dose to the heart and lungs, particularly in left sided breast cancers. No study to date has compared these newer organ-sparing techniques head-to-head for early stage breast cancer.

It is institutional policy to perform CT simulation in left-sided breast cancer patients with and without the respiratory gating (this is one CT scan), in the face-up position. It is also standard of care to perform the face-down CT simulation in large breasted women. Both of these simulations are meant to reduce the exposure of the heart and lungs to radiation. In this study, all left-sided breast cancer patients that consent will receive face-up CT simulation with and without gating AND face-down CT simulation, regardless of breast size; thus, each patient is their own control.

The treating physician will determine which of the two simulations, if any, offers better protection to each patients' heart and lungs. Two dosimetrists will be required to independently verify planned dosimetry with all treatment setups. Treatment will be planned in standard fashion using the best of the two plans.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Prospective Trial of Prone Whole-Breast RadiationTherapy Versus Supine Whole-Breast Radiation Therapy With and Without Respiratory Gating, a Dosimetric Comparison
Study Start Date : September 2013
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Prone/Supine Simulation
It is institutional policy to perform CT simulation in left-sided breast cancer patients with and without the respiratory gating (this is one CT scan), in the face-up position. It is also standard of care to perform the face-down CT simulation in large breasted women. Both of these simulations are meant to reduce the exposure of the heart and lungs to radiation. In this study, all left-sided breast cancer patients that consent will receive face-up CT simulation with and without gating AND face-down CT simulation, regardless of breast size; thus, each patient is their own control.
Other: CT simulation



Primary Outcome Measures :
  1. mean heart dose [ Time Frame: immediate ]
    dosimetric parameter



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Stage 0-IIA left, breast cancer,
  • After lumpectomy or segmental mastectomy,
  • With negative surgical margins

Exclusion Criteria:

  • Right breast cancer
  • Positive surgical margins
  • Stage 2B or higher

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03037723


Locations
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United States, New York
SUNY Upstate Medical University Recruiting
Syracuse, New York, United States, 13210
Contact: Christine S Hall, MS, MEd    315-464-5262    hallcs@upstate.edu   
Principal Investigator: Anna Shapiro, MD         
Sponsors and Collaborators
State University of New York - Upstate Medical University

Publications:

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Responsible Party: Anna Shapiro, Assistant Professor, State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier: NCT03037723     History of Changes
Other Study ID Numbers: 496516
First Posted: January 31, 2017    Key Record Dates
Last Update Posted: January 31, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No