Individual Approach in Gynecological Cancer Brachytherapy | NCT03466957

Studies
Individual Approach in Gynecological Cancer Brachytherapy

NCT03466957

Sponsor

Institute of Oncology Ljubljana

Status

Completed

Last Update Posted

Feb 20, 2026Actual

Enrollment

13Actual

Phase

Not Applicable

Conditions

Cancer

Interventions

3D printed applicator

Countries

Slovenia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2016Actual

Primary Completion Date

May 2018Actual

Completion Date

Jan 2019Actual

First Submitted Date

Mar 1, 2018

First Submission Date that Met QC Criteria

Mar 14, 2018

First Posted Date

Mar 15, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 19, 2026

Last Update Posted Date

Feb 20, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

13Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
3D printed applicator	Experimental	individually designed applicator for BT	Other: 3D printed applicator

Interventions

Name	Type	Description	Arm Group Labels	Other Names
3D printed applicator	Other	add-on cap for oblique needles, 3D printed Vienna-like applicator, individual vaginal cylinder for intracavitary/interstitial application	3D printed applicator

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Helena Barbara Zobec Logar, MD	Brachytherapy Department, Institute of Oncology Ljubljana, Slovenia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institute of Oncology Ljubljana		Ljubljana		1000	Slovenia

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided