Individual Approach in Gynecological Cancer Brachytherapy

Study Overview
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Brief Summary
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MRI guided adaptive brachytherapy (BT) represents the gold standard in the treatment of gynecological cancers. Commercially available standard MRI compatible applicators for BT of gynecological cancers don't always allow for optimal target volume coverage. Three-dimensional (3D) printed technology enables versatile possibilities of improvement of standard applicators and development of novel applicators with better coverage of the target volume. The purpose of this study is to implement and assess 3D printing technology as an instrument for designing and manufacturing applicators for individualized BT of gynecological cancers.

Detailed Description
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Patients with locoregionally gynecological cancers will be included in this single-institution, non-randomized, one-arm study. All patients will receive 45-50 Gy external beam radiotherapy (EBRT) with intensity-modulated radiotherapy/volumetric-modulated arc therapy (IMRT/VMAT) technique, 1.8-2 Gy/fraction +/- concurrent cisplatin based chemotherapy. First BT with commercially available standard applicators (tandem with ring +/- parallel needles or vaginal cylinder) will be carried out. MRI with applicator in situ will be performed, high-risk clinical target volume (CTV-HR) and organs at risk (OAR) will be delineated and treatment planning will be conducted. In the case of large gynecological cancer and suboptimal target coverage at BT (V100 ≤ 90%, D98 ≤ 80%, D90 ≤ 100%, D100 ≤ 60%) a preplan will be performed as the basis for the 3D applicator modelling. The next BT application will be performed with an individually designed 3D printed applicator. Dose-volume characteristics of the following treatment plans will be compared: the preplan, the plan with standard and the plan with individual 3D printed applicator. The primary objective of the study is to determine the improvement of dose-volume parameters with the use of 3D printed individual applicators in advanced gynecological cancer.

Official Title
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Development and Assessment of Individual 3D Printed Applicators in MRI Guided Gynecological Brachytherapy

Conditions
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Cancer

Intervention / Treatment
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* Other: 3D printed applicator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with locally advanced gynecological cancer (cervical, uterine, vaginal, vulvar cancer) eligible for treatment with brachytherapy squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma, histologically proven patients fit for regional or general anesthesia signed written informed consent Exclusion Criteria: regional or general anesthesia contraindications contraindications for MRI

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3D printed applicator<br>individually designed applicator for BT | Other: 3D printed applicator<br>* add-on cap for oblique needles, 3D printed Vienna-like applicator, individual vaginal cylinder for intracavitary/interstitial application<br>* Other names: individual applicator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| target volume CTV-HR | V100 (%), D90 (%), D98 (%), D100 (%) | at two hours after the end of brachytherapy procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| organs at risk | D2cc (Gy), D0.1cc (Gy), Dmax (Gy) | at two hours after the end of brachytherapy procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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image guided brachytherapy, 3D print, gynecological cancer