Patient-tailored 3D-printed ARCHITECT applicator for cervical cancer brachytherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase I, single-center study aims to determine the feasibility of using a patient-tailored, 3D-printed ARCHITECT applicator in image-guided adaptive brachytherapy for locally advanced cervical cancer. Twenty-five patients will receive standard external-beam radiotherapy with concurrent chemotherapy, followed by HDR IGABT using the ARCHITECT applicator to optimize dose delivery to the high-risk target. The study follows EMBRACE II guidelines and evaluates technical practicality, treatment accuracy, and safety within existing clinical protocols. The ARCHITECT design targets optimized source channels to overcome limitations of conventional applicators. Deep hyperthermia is mentioned but not quantified as part of the protocol.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Locally advanced cervical cancer (FIGO 2018 stage 1B3-IVA) with indication for primary radiotherapy including brachytherapy
* Written informed consent

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 the first application for brachytherapy;
* Known nylon allergy.

Where it's running

• Erasmus Medical Center
  Rotterdam, Netherlands Recruiting

Study contacts

• Study coordinator: H. Westerveld, MD, PhD
• Email: g.westerveld@erasmusmc.nl
• Phone: +31 10 704 1249

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.