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NCT Number: NCT03466957

Individual Approach in Gynecological Cancer Brachytherapy

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Individualized 3D-Printed Brachytherapy Applicator

Device

An individualized MRI-compatible brachytherapy applicator is designed based on the participant's anatomy, tumor location, high-risk clinical target volume, and preliminary treatment plan. The applicator is manufactured using 3D-printing technology and may include an add-on cap for oblique needles, an individualized Vienna-type applicator, or an individualized vaginal cylinder for intracavitary and interstitial brachytherapy. The aim is to improve target volume coverage while respecting dose constraints for organs at risk.

Other names: individual applicator

Primary outcomes

  1. Improvement in High-Risk Clinical Target Volume Coverage

    Time frame: During brachytherapy treatment planning, before delivery of the planned brachytherapy dose

    Dose-volume parameters for the high-risk clinical target volume (HR-CTV) will be compared between treatment plans generated with a standard brachytherapy applicator and an individualized 3D-printed applicator within the same participant. Evaluated parameters include D90, D98, D100, and V100. The absolute and relative improvement achieved with the individualized applicator will be reported.

  2. Number of Participants With Grade 3 or Higher Treatment-Related Toxicity

    Time frame: From the first brachytherapy procedure through 60 months after completion of treatment

    Treatment-related toxicity involving the bladder, rectum, bowel, and vagina will be assessed using the Common Terminology Criteria for Adverse Events, version 3.0. The number and percentage of participants with new or worsening grade 3 or higher toxicity will be reported. Vaginal stenosis will be evaluated separately in accordance with the study protocol.

Secondary outcomes

  1. Dose to Organs at Risk

    Time frame: During brachytherapy treatment planning, before delivery of the planned brachytherapy dose

    Dose-volume parameters for organs at risk will be compared between treatment plans generated with the standard and individualized 3D-printed applicators. Evaluated organs include the bladder, rectum, sigmoid colon, and small bowel. Parameters include D2cc, D0.1cc, and maximum dose, expressed in gray.

  2. Local Tumor Control

    Time frame: From completion of treatment through 60 months

    Local control is defined as the absence of persistent or recurrent disease at the anatomical site of the tumor identified on baseline magnetic resonance imaging. Local control will be assessed by clinical and gynecological examinations and by magnetic resonance imaging. The number and percentage of participants with local control will be reported.

Sponsors and collaborators

Lead sponsor

Institute of Oncology Ljubljana

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2030
Study completion
2030
First posted
Mar 15, 2018
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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