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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Patient-tailored, 3D-printed applicator
Erasmus Medical Center
Rotterdam, Netherlands
RECRUITINGClinical feasibility
To deliver brachytherapy using the patient-tailored, 3D printed ARCHITECT applicator \[yes/no\]
Time frame: At week 2 (ARCHITECT applicator)
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)
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)
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)
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)
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Time required for the workflow
Process steps evaluated on time: designing the applicator, processing at manufacturer, processing before use, in operating room, delineating targets and organs-at-risk, reconstructing, treatment planning, checking, treating, removing applicator \[hours:minutes\]
Time frame: At week 1 (standard applicator) and week 2 (ARCHITECT applicator)
Pain perceived by patient
Perceptions of pain will be assessed using the 11-point, Numeric Rating Scale (NRS-11), where 0 indicates "no pain" and 10 represents the "worst imaginable pain"
Time frame: 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
The ARCHITECT applicator will be visually inspected to detect any signs of compromised integrity: breakage \[yes/no\], cracking \[yes/no\], deformation \[yes/no\], material loss \[yes/no\].
Time frame: At week 2 (ARCHITECT applicator): after removal from the patient