3D Printed Bolus in Post-mastectomy Radiotherapy

NCT ID: NCT04685460

Last Updated: 2021-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-01

Study Completion Date

2021-04-20

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Neoplasms Radiotherapy Side Effect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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3D-printed bolus

Group Type EXPERIMENTAL

customized 3D-printed bolus fabricated based on reconstruction of computed tomography (CT) images

Intervention Type OTHER

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

Conventional bolus

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* breast cancer patients with post-mastectomy treatment

Exclusion Criteria

* NA
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jiangxi Provincial Cancer Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Jiangxi Cancer Hospital of Nanchang University

Nanchang, Jiangxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Chunling Jiang, Phd,MD

Role: CONTACT

+8613979109200 ext. 330029

Facility Contacts

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Chunling Jiang, MD,PHD

Role: primary

+8613979109200

Other Identifiers

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jcl2020-2 breast cancer

Identifier Type: -

Identifier Source: org_study_id

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