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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/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)
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Scientific title
Study of 3D-printed Custom Applicators for Intracavitary HDR Gynaecological Brachytherapy (DISCO)
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Secondary ID [1]
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DISCO
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Gynecologic Cancer
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Endometrial Cancer
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Vaginal Cancer
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Vulva Cancer
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Condition category
Condition code
Cancer
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Womb (Uterine or endometrial cancer)
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Cancer
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0
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Other cancer types
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Reproductive Health and Childbirth
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0
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Other reproductive health and childbirth disorders
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Successful treatment of gynaecological HDR brachytherapy patients with 3D printed intracavitary applicators.
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Assessment method [1]
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To demonstrate the feasibility of successfully simulating, planning and treating a HDR BT gynaecological patient with a 3D-printed internal mould, such that there is a dosimetric and/or clinical benefit for the patient relative to the current standard of care (cylindrical vaginal applicator). Successful treatment indicated by achieving no adverse events or difference to standard of care, and dosimentic comparisons of the 3D printed applicator plan to the cylinder plan are equivalent or better. Feasibility also determined by achieving no logistical or design issues in using the 3D printed applicators clinically.
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Timepoint [1]
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5 years
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Secondary outcome [1]
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To assess the patients radiation therapy acute and late toxicities using the CTCAE criteria
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Assessment method [1]
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RT acute and late side effects will be assessed and quantified using CTCAE criteria via clinician assessment and PROs
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Timepoint [1]
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5 years
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Secondary outcome [2]
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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.
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Assessment method [2]
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The plan quality of treatment plans generated for 3D-printed moulds and cylindrical applicators will be compared using dosimetric indices including target coverage (D90, Dose Homogeneity index) and organs at risk doses (D2cc, D1cc and point max) as well as patient comfort. statistical analysis (p-value) and comparison with international guidelines will be used to assess the quality of the treatment plans.
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Timepoint [2]
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5 years
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Secondary outcome [3]
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Determine feasibility of a pre-planned MR-only procedure
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Assessment method [3]
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Feasibility of a pre-planned MR-only procedure will be determined using any of the patients that are accrued to the study who have both a CT and MRI performed at the time of simulation. The applicator and treatment plan will be generated based on the MRI and both compared to the CT-based plan and applicator. Feasibility will be indicated by generating equivalent plan quality and applicators from both methods.
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Timepoint [3]
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5 years
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Secondary outcome [4]
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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).
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Assessment method [4]
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The initial and final CT plan dosimetry will be compared to determine the feasibility of an initial CT-only process. Clinically insignificant differences between the plan dosimetry metrics and all within clinical tolerances will be used to quantify the difference. statistical analysis (p-value) will be used to assess the quality of the treatment plans.
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Timepoint [4]
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5 years
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Secondary outcome [5]
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Determine feasibility of optimising 3D-printed applicator design based on the cylinder fitting procedure
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Assessment method [5]
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The feasibility of an optimised 3D-printed applicator design based on the cylinder fitting procedure will be assessed by comparison of the 3D-printed clinical applicators with applicators derived from CT/MR of the vault in a relaxed state with an expansion applied based on the size of the cylinder applied in the fitting procedure. Feasibility will be determined by looking for a correlation between the size of the 3D printed clinical applicators and the size of the cylinders tolerated by the patient in the fitting procedure.
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Timepoint [5]
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5 years
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Secondary outcome [6]
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To measure resources such as procedure times and demonstrate acceptable timescales for the process
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Assessment method [6]
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Procedure times will be recorded as per ARIA carepath tasks and time taken within the 3D-printed custom applicator workflow compared to the standard of care cylinder applicator workflow with equivalent or less time taken deemed acceptable
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Timepoint [6]
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5 years
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Secondary outcome [7]
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To define the resource costs associated with the 3D-printed design process and perform a cost comparison with the standard of care process
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Assessment method [7]
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Costs associated with the 3D-printed design process will be defined and compared with the standard of care process via economic analysis of the resourcing and unit-price estimates in each arm of the respective workflows
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Timepoint [7]
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5 years
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Secondary outcome [8]
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To assess patient experience and acceptability of the process with questionnaires
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Assessment method [8]
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Patient experience and acceptability of the 3D-printed simulation and treatment processes will be assessed with the EORTC QLQ-C30 questionnaires and success measured by comparison with the standard of care vaginal cylinder process. Questionnaires include questions with a scale of 1-4 where a higher number indicates a worse experience and a scale of 1-7 where a lower number indicates a worse experience.
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Timepoint [8]
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5 years
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
24/11/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/09/2028
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Actual
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Sample size
Target
10
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Royal North Shore Hospital - St Leonards
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Recruitment postcode(s) [1]
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2067 - St Leonards
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Funding & Sponsors
Primary sponsor type
Other
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Name
Royal North Shore Hospital
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT06432478
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Marita Morgia, MD
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Address
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Royal North Shore Hospital
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Marita Morgia, MD
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Address
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Country
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Phone
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9463 1300
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Fax
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Email
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[email protected]
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06432478
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