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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06432478




Registration number
NCT06432478
Ethics application status
Date submitted
11/01/2024
Date registered
29/05/2024
Date last updated
29/05/2024

Titles & IDs
Public title
3D Printed Custom Applicators for HDR BT (DISCO)
Scientific title
Study of 3D-printed Custom Applicators for Intracavitary HDR Gynaecological Brachytherapy (DISCO)
Secondary ID [1] 0 0
DISCO
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gynecologic Cancer 0 0
Endometrial Cancer 0 0
Vaginal Cancer 0 0
Vulva Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)
Cancer 0 0 0 0
Other cancer types
Reproductive Health and Childbirth 0 0 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - 3D-printed custom applicator

Experimental: Gynaecological HDR brachytherapy patients - Using 3D-printed custom applicators to treat gynaecological HDR brachytherapy patients


Treatment: Devices: 3D-printed custom applicator
3D-printed custom applicator
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Successful treatment of gynaecological HDR brachytherapy patients with 3D printed intracavitary applicators.
Timepoint [1] 0 0
5 years
Secondary outcome [1] 0 0
To assess the patients radiation therapy acute and late toxicities using the CTCAE criteria
Timepoint [1] 0 0
5 years
Secondary outcome [2] 0 0
To compare quality of treatment plans generated for 3D-printed moulds and cylindrical applicators assessed by dosimetric indices, statistical analysis (p-value) and comparison with international guidelines.
Timepoint [2] 0 0
5 years
Secondary outcome [3] 0 0
Determine feasibility of a pre-planned MR-only procedure
Timepoint [3] 0 0
5 years
Secondary outcome [4] 0 0
To determine the feasibility of an initial CT-only process by comparing initial and final CT plan dosimetry assessed by dosimetric indices, clinical tolerances, and statistical analysis (p-value).
Timepoint [4] 0 0
5 years
Secondary outcome [5] 0 0
Determine feasibility of optimising 3D-printed applicator design based on the cylinder fitting procedure
Timepoint [5] 0 0
5 years
Secondary outcome [6] 0 0
To measure resources such as procedure times and demonstrate acceptable timescales for the process
Timepoint [6] 0 0
5 years
Secondary outcome [7] 0 0
To define the resource costs associated with the 3D-printed design process and perform a cost comparison with the standard of care process
Timepoint [7] 0 0
5 years
Secondary outcome [8] 0 0
To assess patient experience and acceptability of the process with questionnaires
Timepoint [8] 0 0
5 years

Eligibility
Key inclusion criteria
- Able to give informed consent

- Patients indicated for intracavitary brachytherapy

- FIGO stage I-IVA

- ECOG 0-2

- Primary endometrial cancer, primary vaginal cancer, primary vulva cancer, recurrent
gynaecological cancer
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Pregnancy

- Patients contraindicated for brachytherapy

- Inflammatory bowel disease/history of adhesions/bowel obstruction

- Renal transplant/horseshoe kidney

- Patients with significant LVSI or pelvic sidewall invasion

- Patients requiring interstitial brachytherapy implants

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/11/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2028
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 0 0
2067 - St Leonards

Funding & Sponsors
Primary sponsor type
Other
Name
Royal North Shore Hospital
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Intracavitary brachytherapy for gynaecological cancer currently use cylinder-type applicators
or custom wax moulds to place a radioactive source in close proximity to the treatment area
and provide highly conformal dose distributions. This study is a Phase IIa non-randomised
interventional pilot trial that will investigate the feasibility of successfully treating
patients with 3D-printed custom applicators.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06432478
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Marita Morgia, MD
Address 0 0
Royal North Shore Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Marita Morgia, MD
Address 0 0
Country 0 0
Phone 0 0
9463 1300
Fax 0 0
Email 0 0
Marita.Morgia@health.nsw.gov.au
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06432478