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The Influence of Treatment Position (Prone vs. Supine) on Whole Breast Target

Primary Purpose

Breast Cancer

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
dedicated treatment board with no degree
Sponsored by
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Breast cancer, radiotherapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Breast cancer patients with T1-T2N0M0 stage who underwent radiation therapy after conserving surgery exhibited normal arm movement aſter surgery had no chronic lung diseases Written informed consent forms Exclusion Criteria: Breast cancer patients with radical surgery could not exhibit normal arm movement after surgery had chronic lung diseases refused informed consent forms

Sites / Locations

  • Shanxi provicial cancer hospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Breast cancer underwent scanning in the supine position

Arm Description

Breast cancer patients with T1-2N0M0 stage who underwent radiation therapy after conserving surgery were enrolled. Supine scan sets were acquired during free breathing for all patients. Target volumes and organs at risk (OARs) including heart, ipsilateral lung and bilateral breast were contoured by the same radiation oncologist. The tumor bed (TB) was determined based on surgical clips. The Clinical target volume (CTV)consisted of the whole breast. The planning target volume (PTV) was CTV plus 0.5cm. The boost of PTV (PTVboost) was TB plus 0.5cm.

Outcomes

Primary Outcome Measures

dose distribution of GTV
the difference of GTV (Gross tumor target) between two plans
dose distribution of CTV
the difference of CTV (clinical target volume) between two plans
dose distribution of PTV
the difference of PTV (planing target volume) between two plans
dose distribution of heart
the difference of heart dose distribution between two plans
dose distribution of ipsilateral lung
the difference of ipsilateral lung dose distribution between two plans
dose distribution of bilateral breasts
the difference of bilateral breasts dose distribution between two plans

Secondary Outcome Measures

Full Information

First Posted
October 24, 2022
Last Updated
January 28, 2023
Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05609058
Brief Title
The Influence of Treatment Position (Prone vs. Supine) on Whole Breast Target
Official Title
The Influence of Treatment Position (Prone vs. Supine) on Whole Breast Irradiation for Chinese Breast Cancer Patients :Comparative Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
November 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Radiotherapy after breast conserving therapy plays an important role in early stage breast cancer patients. It not only results in a reduction in local and regional recurrence but also decrease the death rate effectively. For adjuvant radiotherapy, supine positioning is the most common approach and has multiple advantages. Due to deformability and softness of the breast, during simulation and treatment in supine position, the breast stretches over the chest wall, especially in patients with large and pendulous glands. Thus the organs at risk (OARs) received dose increased. The radiotherapeutic toxicity are unavoidable. Some present studies show that the prone positioning of patients can improve dose homogeneity and reduce the dose distribution in OARs in patients with large and pendulous glands. Chinese women have relatively small breasts, the advantages of those have not been established. Therefore, investigators compared the parameters between supine and prone positions for whole breast irradiation after conserving surgery.
Detailed Description
Objective To investigate the difference of target volumes and dosimetric parameters between supine and prone positions for whole breast irradiation after conserving surgery. Methods Breast cancer patients with T1-2N0M0 stage who underwent radiation therapy after conserving surgery were enrolled. Supine and Prone scan sets were acquired during free breathing for all patients. Target volumes and organs at risk (OARs) including heart, ipsilateral lung and bilateral breast were contoured by the same radiation oncologist. The tumor bed (TB) was determined based on surgical clips. The Clinical target volume (CTV)consisted of the whole breast. The planning target volume (PTV) was CTV plus 0.5cm. The boost of PTV (PTVboost) was TB plus 0.5cm. Dosimetric parameters of target volumes and OARs were compared between supine and prone position.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast cancer, radiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Breast cancer patients with T1-T2N0M0 stage who underwent radiation therapy after conserving surgery were enrolled. Supine and Prone scan sets were acquired during free breathing for all patients. Target volumes and organs at risk (OARs) including heart, ipsilateral lung and bilateral breast were contoured by the same radiation oncologist.
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Breast cancer underwent scanning in the supine position
Arm Type
Experimental
Arm Description
Breast cancer patients with T1-2N0M0 stage who underwent radiation therapy after conserving surgery were enrolled. Supine scan sets were acquired during free breathing for all patients. Target volumes and organs at risk (OARs) including heart, ipsilateral lung and bilateral breast were contoured by the same radiation oncologist. The tumor bed (TB) was determined based on surgical clips. The Clinical target volume (CTV)consisted of the whole breast. The planning target volume (PTV) was CTV plus 0.5cm. The boost of PTV (PTVboost) was TB plus 0.5cm.
Intervention Type
Device
Intervention Name(s)
dedicated treatment board with no degree
Intervention Description
the patients were placed in the prone position on a dedicated treatment board with no degree incline using an arm support (with both arms above the head). Te board contained an open aperture on one side to allow for the ipsilateral breast to hang freely away from the chest wall
Primary Outcome Measure Information:
Title
dose distribution of GTV
Description
the difference of GTV (Gross tumor target) between two plans
Time Frame
1 year
Title
dose distribution of CTV
Description
the difference of CTV (clinical target volume) between two plans
Time Frame
1 year
Title
dose distribution of PTV
Description
the difference of PTV (planing target volume) between two plans
Time Frame
1 year
Title
dose distribution of heart
Description
the difference of heart dose distribution between two plans
Time Frame
1 year
Title
dose distribution of ipsilateral lung
Description
the difference of ipsilateral lung dose distribution between two plans
Time Frame
1 year
Title
dose distribution of bilateral breasts
Description
the difference of bilateral breasts dose distribution between two plans
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Breast cancer patients with T1-T2N0M0 stage who underwent radiation therapy after conserving surgery exhibited normal arm movement aſter surgery had no chronic lung diseases Written informed consent forms Exclusion Criteria: Breast cancer patients with radical surgery could not exhibit normal arm movement after surgery had chronic lung diseases refused informed consent forms
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ning Li
Phone
13521952929
Email
liningnci@126.com
Facility Information:
Facility Name
Shanxi provicial cancer hospital
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ning Li
Phone
13521952929
Email
liningnci@126.com

12. IPD Sharing Statement

Learn more about this trial

The Influence of Treatment Position (Prone vs. Supine) on Whole Breast Target

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