3D Printed Bolus in Post-mastectomy Radiotherapy
Clinical Study of 3D Printed Bolus for Volumetric Modulated Arc Therapy of Post-mastectomy Treatment
1 other identifier
interventional
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2020
CompletedFirst Submitted
Initial submission to the registry
November 18, 2020
CompletedFirst Posted
Study publicly available on registry
December 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 20, 2021
CompletedApril 19, 2021
November 1, 2020
1.1 years
November 18, 2020
April 14, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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
one year
Study Arms (2)
3D-printed bolus
EXPERIMENTALConventional bolus
NO INTERVENTIONInterventions
customized 3D-printed bolus fabricated based on reconstruction of computed tomography (CT) images were used in this study.
Eligibility Criteria
You may qualify if:
- breast cancer patients with post-mastectomy treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jiangxi Cancer Hospital of Nanchang University
Nanchang, Jiangxi, 330029, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 18, 2020
First Posted
December 28, 2020
Study Start
March 1, 2020
Primary Completion
April 15, 2021
Study Completion
April 20, 2021
Last Updated
April 19, 2021
Record last verified: 2020-11