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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03466957
Other study ID # ERID-KESOPKR/63
Secondary ID
Status Recruiting
Phase N/A
First received March 1, 2018
Last updated March 14, 2018
Start date May 2016
Est. completion date January 2019

Study information

Verified date March 2018
Source Institute of Oncology Ljubljana
Contact Helena Barbara Zobec Logar, MD
Phone 0038615879204
Email hlogar@onko-i.si
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 13
Est. completion date January 2019
Est. primary completion date May 2018
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 85 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
3D printed applicator
add-on cap for oblique needles, 3D printed Vienna-like applicator, individual vaginal cylinder for intracavitary/interstitial application

Locations

Country Name City State
Slovenia Institute of Oncology Ljubljana Ljubljana

Sponsors (1)

Lead Sponsor Collaborator
Institute of Oncology Ljubljana

Country where clinical trial is conducted

Slovenia, 

Outcome

Type Measure Description Time frame Safety issue
Primary target volume CTV-HR V100 (%), D90 (%), D98 (%), D100 (%) at two hours after the end of brachytherapy procedure
Secondary organs at risk D2cc (Gy), D0.1cc (Gy), Dmax (Gy) at two hours after the end of brachytherapy procedure
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