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3D Printed Bolus in Post-mastectomy Radiotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04685460
Recruitment Status : Recruiting
First Posted : December 28, 2020
Last Update Posted : April 19, 2021
Information provided by (Responsible Party):
Jiangxi Provincial Cancer Hospital

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.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Radiotherapy Side Effect Other: customized 3D-printed bolus fabricated based on reconstruction of computed tomography (CT) images Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Clinical Study of 3D Printed Bolus for Volumetric Modulated Arc Therapy of Post-mastectomy Treatment
Actual Study Start Date : March 1, 2020
Actual Primary Completion Date : April 15, 2021
Estimated Study Completion Date : April 20, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mastectomy

Arm Intervention/treatment
Experimental: 3D-printed bolus 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.

No Intervention: Conventional bolus

Primary Outcome Measures :
  1. dose comparison [ Time Frame: one year ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • breast cancer patients with post-mastectomy treatment

Exclusion Criteria:

  • NA

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04685460

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Contact: Chunling Jiang, Phd,MD +8613979109200 ext 330029

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China, Jiangxi
Jiangxi Cancer Hospital of Nanchang University Recruiting
Nanchang, Jiangxi, China, 330029
Contact: Chunling Jiang, MD,PHD    +8613979109200   
Sponsors and Collaborators
Jiangxi Provincial Cancer Hospital
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Responsible Party: Jiangxi Provincial Cancer Hospital Identifier: NCT04685460    
Other Study ID Numbers: jcl2020-2 breast cancer
First Posted: December 28, 2020    Key Record Dates
Last Update Posted: April 19, 2021
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases