Clinical Feasibility of the ARCHITECT Applicator in Cervical Cancer Brachytherapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorErasmus Medical Center
About this trial
This prospective, non-randomised, single centre, phase I trial assesses the clinical feasibility of the use of the patient-tailored ARCHITECT applicator in locally advanced cervical cancer brachytherapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Locally advanced cervical cancer (FIGO 2018 stage 1B3-IVA) with indication for primary radiotherapy including brachytherapy
Written informed consent
Disqualifiers
Unable to give informed consent;
Tumour extension in the lower 2/3rd of the vagina;
Requiring a Geneva tandem with ovoids' size 13 mm in the first application for brachytherapy;
Known nylon allergy.
Trial design
Design model
Single group
Treatments tested in this trial
ARCHITECT applicator
DevicePatient-tailored, 3D-printed applicator
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: Study armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Clinical feasibility
To deliver brachytherapy using the patient-tailored, 3D printed ARCHITECT applicator \[yes/no\]
Time frame
At week 2 (ARCHITECT applicator)Secondary outcomes
1
Brachytherapy-related adverse events
Organ perforation, vaginal bleeding, and device-related infection according to the common terminology criteria for adverse events (CTCAE) version 5
Time frame
At week 1 (standard applicator) and week 2 (ARCHITECT applicator): based on imaging (organ perforation), <1 hour after applicator removal (vaginal bleeding), <1-2 weeks after removal from the patient (device-related infection)2
Brachytherapy plan quality
Dosimetric parameters (according to EMBRACE II): High-Risk Clinical Target Volume D90, High-Risk Clinical Target Volume D98, Intermediate-Risk Clinical Target Volume D98, and bladder , rectum , sigmoid , and bowel D2cm3 \[Gy\]
Time frame
At week 1 (standard applicator) and week 2 (ARCHITECT applicator)3
Brachytherapy implant geometry
Optimal geometry of applicator, i.e. number of needles and spacing between needles \[mm\]
Time frame
At week 1 (standard applicator) and week 2 (ARCHITECT applicator)4
User experience
Questions on a scale of 1-5 where 1 indicates "strongly disagree" and 5 "strongly agree" on following the topics: easy to insert applicator, easy to connect applicator to tandem, easy to insert the needles in terms of force, easy to reach required depth with needles, easy to fixate the needles, applicator fits well, easy to remove applicator and needles, easy to reconstruct applicator or needles, applicator did not move, needles did not move, easy to connect and disconnect to after loader.
Time frame
At week 1 (standard applicator) and 2 (ARCHITECT applicator)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov