3D Printed Bolus in Post-mastectomy Radiotherapy

Breast Neoplasms Clinical Trial

Official title:

Clinical Study of 3D Printed Bolus for Volumetric Modulated Arc Therapy of Post-mastectomy Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04685460
• Other study ID #: jcl2020-2 breast cancer
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: April 20, 2021

Study information

• Verified date: November 2020
• Source: Jiangxi Provincial Cancer Hospital
• Contact: Chunling Jiang, Phd,MD
• Phone: +8613979109200
• Email: jclil2002[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: April 20, 2021
• Est. primary completion date: April 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• breast cancer patients with post-mastectomy treatment

Exclusion Criteria:

• NA

Related Conditions & MeSH terms

• Breast Neoplasms
• Radiotherapy Side Effect

Intervention

Other:
• customized 3D-printed bolus fabricated based on reconstruction of computed tomography (CT) images
customized 3D-printed bolus fabricated based on reconstruction of computed tomography (CT) images were used in this study.

Locations

Country	Name	City	State
China	Jiangxi Cancer Hospital of Nanchang University	Nanchang	Jiangxi

Sponsors (1)

Lead Sponsor	Collaborator
Jiangxi Provincial Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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