Clinical Feasibility of the ARCHITECT Applicator in Cervical Cancer Brachytherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ARCHITECT applicator.
- Who it may be relevant to
- Registry conditions: Locally Advanced Cervical Cancer, Uterine Carcinoma. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Clinical Feasibility of the ARCHITECT Applicator in High-dose-rate Cervical Cancer Brachytherapy
Overview
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
- Device ARCHITECT applicator
Patient-tailored, 3D-printed applicator
Primary outcome measures
- Clinical feasibility [Time frame: At week 2 (ARCHITECT applicator)]
Secondary outcome measures (7)
- Brachytherapy-related adverse events [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 [Time frame: At week 1 (standard applicator) and week 2 (ARCHITECT applicator)]
- Brachytherapy implant geometry [Time frame: At week 1 (standard applicator) and week 2 (ARCHITECT applicator)]
- User experience [Time frame: At week 1 (standard applicator) and 2 (ARCHITECT applicator)]
- Time required for the workflow [Time frame: At week 1 (standard applicator) and week 2 (ARCHITECT applicator)]
- Pain perceived by patient [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 [Time frame: At week 2 (ARCHITECT applicator): after removal from the patient]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Netherlands · 1 center
- Erasmus Medical Center — Rotterdam
Publications
- Straathof R, van Vliet-Perez SM, Kolkman-Deurloo IK, Wauben LSGL, Nout RA, Heijmen BJM, Rossi L, Dankelman J, van de Berg NJ. Automated planning of curved needle channels in 3D printed patient-tailored applicators for cervical cancer brachytherapy. Phys Med Biol. 2024 Nov 25;69(23). doi: 10.1088/1361-6560/ad8b08. PMID 39447602
Identifiers
NCT: NCT07435987 · NL-011333