Locally Advanced Cervical Cancer, Uterine Carcinoma
Conditions
Keywords
Brachytherapy, Patient-tailored applicator, 3D-printed applicator
Brief summary
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.
Detailed description
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.
Interventions
DEVICEARCHITECT applicator
Patient-tailored, 3D-printed applicator
Sponsors
Erasmus Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical feasibility | At week 2 (ARCHITECT applicator) | To deliver brachytherapy using the patient-tailored, 3D printed ARCHITECT applicator \[yes/no\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Brachytherapy-related adverse events | 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) | Organ perforation, vaginal bleeding, and device-related infection according to the common terminology criteria for adverse events (CTCAE) version 5 |
| Brachytherapy plan quality | At week 1 (standard applicator) and week 2 (ARCHITECT applicator) | 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 \[Gy\] |
| Brachytherapy implant geometry | At week 1 (standard applicator) and week 2 (ARCHITECT applicator) | Optimal geometry of applicator, i.e. number of needles and spacing between needles \[mm\] |
| User experience | At week 1 (standard applicator) and 2 (ARCHITECT applicator) | 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 required for the workflow | At week 1 (standard applicator) and week 2 (ARCHITECT applicator) | 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 \[hours:minutes\] |
| Pain perceived by patient | 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 | 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" |
| Integrity of the patient-tailored applicator | At week 2 (ARCHITECT applicator): after removal from the patient | 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 \[yes/no\]. |
Countries
Netherlands
Contacts
CONTACTH. Westerveld, MD, PhD
Outcome results
None listed