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Recruiting NCT06432478

3D Printed Custom Applicators for HDR BT (DISCO)

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Trial Parameters

Condition Gynecologic Cancer
Sponsor Royal North Shore Hospital
Study Type INTERVENTIONAL
Phase N/A
Enrollment 10
Sex FEMALE
Min Age 18 Years
Max Age N/A
Start Date 2023-11-24
Completion 2028-09
Interventions
3D-printed custom applicator

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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.

Eligibility Criteria

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 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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