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Trial Title:
The Influence of Treatment Position (Prone vs. Supine) on Whole Breast Target
NCT ID:
NCT05609058
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Breast cancer
radiotherapy
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention 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.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
dedicated treatment board with no degree
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
Arm group label:
Breast cancer underwent scanning in the supine position
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Breast cancer patients with T1-T2N0M0 stage who underwent radiation therapy after
conserving surgery
2. exhibited normal arm movement aſter surgery
3. had no chronic lung diseases
4. Written informed consent forms
Exclusion Criteria:
1. Breast cancer patients with radical surgery
2. could not exhibit normal arm movement after surgery
3. had chronic lung diseases
4. refused informed consent forms
Gender:
Female
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanxi provicial cancer hospital
Address:
City:
Taiyuan
Zip:
030001
Country:
China
Status:
Recruiting
Contact:
Last name:
Ning Li
Phone:
13521952929
Email:
liningnci@126.com
Start date:
January 1, 2019
Completion date:
November 1, 2023
Lead sponsor:
Agency:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Agency class:
Other
Source:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05609058
