3D Printed Bolus in Post-mastectomy Radiotherapy
Primary Purpose
Breast Neoplasms, Radiotherapy Side Effect
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
customized 3D-printed bolus fabricated based on reconstruction of computed tomography (CT) images
Sponsored by
About this trial
This is an interventional treatment trial for Breast Neoplasms
Eligibility Criteria
Inclusion Criteria:
- breast cancer patients with post-mastectomy treatment
Exclusion Criteria:
- NA
Sites / Locations
- Jiangxi Cancer Hospital of Nanchang UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
3D-printed bolus
Conventional bolus
Arm Description
Outcomes
Primary Outcome Measures
dose comparison
The prescription dose was 50 Gy in 25 fractions. Dose-volume histograms (DVHs) were used dosimetric analysis. D98%, D50% and D2%, indicating dose to 98% (near-minimum dose), 50% and 2% (near-maximum dose) of both target volumes, and V95%, V100%, and V110% indicating percent volume receiving 95%, 100% and 110% of prescribed dose, were recorded
Secondary Outcome Measures
Full Information
NCT ID
NCT04685460
First Posted
November 18, 2020
Last Updated
April 14, 2021
Sponsor
Jiangxi Provincial Cancer Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04685460
Brief Title
3D Printed Bolus in Post-mastectomy Radiotherapy
Official Title
Clinical Study of 3D Printed Bolus for Volumetric Modulated Arc Therapy of Post-mastectomy Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
April 15, 2021 (Actual)
Study Completion Date
April 20, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangxi Provincial Cancer Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Recently, there is growing interest in the application of three-dimensional (3D) printed bolus to radiotherapy.At present, the researches on the application of 3D-printed bolus in breast cancer are mainly focused on air gap between skin and bolus or electron beam conformal therapy [7,15], there are no clinical experience with customized 3D-printed bolus for volumetric modulated arc therapy (VMAT) in daily practice has been published up to now. We aim to evaluate dosimetry and application of 3D-printed bolus for the post-mastectomy radiotherapy (PMRT) with Volumetric modulated arc therapy (VMAT). Seventy five patients with breast cancer receiving radiotherapy following post-mastectomy in our department were randomly selected in this study. The accuracy of fit of the 3D-Printed bolus to the chest wall was improved significantly relative to conventional bolus.This study demonstrates customized 3D-printed bolus in post-mastectomy radiation therapy improves fit of the bolus compared to conventional bolus. Furthermore, VMAT based on 3D-printed bolus significantly improves the chest wall target coverage and the conformity of plan, and reduces the dose of ipsilateral lung and heart, compared to conventional bolus.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms, Radiotherapy Side Effect
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
3D-printed bolus
Arm Type
Experimental
Arm Title
Conventional bolus
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
customized 3D-printed bolus fabricated based on reconstruction of computed tomography (CT) images
Intervention Description
customized 3D-printed bolus fabricated based on reconstruction of computed tomography (CT) images were used in this study.
Primary Outcome Measure Information:
Title
dose comparison
Description
The prescription dose was 50 Gy in 25 fractions. Dose-volume histograms (DVHs) were used dosimetric analysis. D98%, D50% and D2%, indicating dose to 98% (near-minimum dose), 50% and 2% (near-maximum dose) of both target volumes, and V95%, V100%, and V110% indicating percent volume receiving 95%, 100% and 110% of prescribed dose, were recorded
Time Frame
one year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
breast cancer patients with post-mastectomy treatment
Exclusion Criteria:
NA
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chunling Jiang, Phd,MD
Phone
+8613979109200
Ext
330029
Email
jclil2002@163.com
Facility Information:
Facility Name
Jiangxi Cancer Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chunling Jiang, MD,PHD
Phone
+8613979109200
Email
jclil2002@163.com
12. IPD Sharing Statement
Learn more about this trial
3D Printed Bolus in Post-mastectomy Radiotherapy
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