Individual Approach in Gynecological Cancer Brachytherapy

NCT ID: NCT03466957

Last Updated: 2018-03-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2019-01-31

Brief 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.

Detailed 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.

Conditions

Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

3D printed applicator

individually designed applicator for BT

Group Type: EXPERIMENTAL

3D printed applicator

Intervention Type: OTHER

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

Interventions

3D printed applicator

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

Intervention Type: OTHER

Other Intervention Names

individual applicator

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Institute of Oncology Ljubljana

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Helena Barbara Zobec Logar, MD

Role: PRINCIPAL_INVESTIGATOR

Brachytherapy Department, Institute of Oncology Ljubljana, Slovenia

Locations

Institute of Oncology Ljubljana

Ljubljana, , Slovenia

Site Status: RECRUITING

Countries

Slovenia

Central Contacts

Helena Barbara Zobec Logar, MD

Role: CONTACT

hlogar@onko-i.si

0038615879204

Facility Contacts

Violeta Kaluza

Role: primary

vkaluza@onko-i.si

0038115879122

Other Identifiers

ERID-KESOPKR/63

Identifier Type: -

Identifier Source: org_study_id