Clinical Feasibility of the ARCHITECT Applicator in Cervical Cancer Brachytherapy

Image-guided adaptive brachytherapy is an essential part of the standard treatment of locally advanced cervical cancer (LACC). During LACC brachytherapy, a radioactive source is guided through an applicator implanted in the vaginal and uterine cavity, as well as through interstitial needles near or inside the tumour tissue. However, in certain patient groups, current commercially available applicators cannot meet dose objectives. Alternative approaches are technically challenging and dependent on the clinician's experience.

In the ARCHITECT project, a single-use, 3D printed, patient-tailored applicator with optimised source channels is developed to overcome these limitations. The aim of this phase I study is to evaluate the clinical feasibility of the ARCHTECT applicator in brachytherapy for LACC.

Twenty-five patients with LACC will be treated with the standard treatment for LACC in concordance with the EMBRACE II protocol and (inter)national guidelines, including external beam radiation therapy (45 Gy in 25 fx with simultaneous integrated nodal boost in case of suspicion of lymph node metastases), concurrent weekly chemotherapy (cisplatin 40 mg/m2), and high-dose rate (HDR) image-guided adaptive brachytherapy (IGABT). HDR IGABT will be performed following the latest clinical guidelines, including 21-28 Gy in 3 to 4 fractions of 7 Gy, aiming for a total cumulative (EBRT+IGABT) dose of 90-95 Gy (EQD210 D90) to the high-risk-clinical target volume (CTV-THR). Deep hyperthermia in five sessions or no sensitizing therapy during EBRT is also allowed.

In general in Erasmus Medical Centre, two applications are applied with an interval of one week for the brachytherapy part. Patients will be treated with a commercially available applicator (conform the current clinical practice) at week 1 and with the patient-tailored ARCHITECT applicator (study intervention) at week 2.

• Brachytherapy-related adverse events [Срок оценки: 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)]
• Brachytherapy plan quality [Срок оценки: At week 1 (standard applicator) and week 2 (ARCHITECT applicator)]
• Brachytherapy implant geometry [Срок оценки: At week 1 (standard applicator) and week 2 (ARCHITECT applicator)]
• User experience [Срок оценки: At week 1 (standard applicator) and 2 (ARCHITECT applicator)]
• Time required for the workflow [Срок оценки: At week 1 (standard applicator) and week 2 (ARCHITECT applicator)]
• Pain perceived by patient [Срок оценки: At week 1 (standard applicator) and week 2 (ARCHITECT applicator): <1 hour before the patient arrives at operating room, after each MR or CT imaging, and after removal from the patient]
• Integrity of the patient-tailored applicator [Срок оценки: At week 2 (ARCHITECT applicator): after removal from the patient]