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A patient specific applicator for brachytherapy in cervical cancer

Clinical feasibility of the ARCHITECT applicator in high-dose-rate cervical cancer brachytherapy - ARCHITECT phase I

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON61305
Enrollment
25
Registered
2026-01-08
Start date
2026-07-21
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally advanced cervical cancer

Interventions

The 3D-printed, patient-tailored ARCHITECT applicator

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 18 years or older;Locally advanced cervical cancer (FIGO stage 1B3-IVA) with indication for primary radiotherapy including brachytherapy;Written informed consent

Exclusion criteria

Exclusion criteria: 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 BT1;Known nylon allergy

Design outcomes

Primary

MeasureTime frame
The clinical feasibility of the use of the patient-tailored ARCHITECT applicator in locally advanced cervical cancer brachytherapy will be assessed. This is defined as the ability to treat the patient during the second application using the 3D printed patient-tailored applicator.

Secondary

MeasureTime frame
Brachytherapy-related adverse events, brachytherapy implant geometry and plan quality, user experience, time required for the workflow, pain perceived by the patient during the day of the IGABT, and integrity of the patient-tailored applicator will be evaluated.

Countries

Netherlands

Contacts

Public ContactH. Westerveld

Erasmus MC, Universitair Medisch Centrum Rotterdam

g.westerveld@erasmusmc.nl+31 (0) 107039751

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Aug 10, 2026