Clinical Feasibility of the ARCHITECT Applicator in Cervical Cancer Brachytherapy (ARCHITECT)

February 20, 2026 updated by: Dr. G.H. (Henrike) Westerveld, Erasmus Medical Center

Clinical Feasibility of the ARCHITECT Applicator in High-dose-rate Cervical Cancer Brachytherapy

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Netherlands
      • Rotterdam, Netherlands, 3015 GD
        • Erasmus Medical Center
        • Contact:
        • Principal Investigator:
          • H. Westerveld, MD, PhD
        • Sub-Investigator:
          • A. Corbeau, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Study arm
In general in Erasmus Medical Centre, two applications are applied with an interval of one week for the HDR IGABT. 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.
Device: ARCHITECT applicator
Patient-tailored, 3D-printed applicator

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Clinical feasibility
Time Frame: At week 2 (ARCHITECT applicator)
To deliver brachytherapy using the patient-tailored, 3D printed ARCHITECT applicator [yes/no]
At week 2 (ARCHITECT applicator)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
Organ perforation, vaginal bleeding, and device-related infection according to the common terminology criteria for adverse events (CTCAE) version 5
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)
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]
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)
Optimal geometry of applicator, i.e. number of needles and spacing between needles [mm]
At week 1 (standard applicator) and week 2 (ARCHITECT applicator)
User experience
Time Frame: 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.
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)
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]
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
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"
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
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].
At week 2 (ARCHITECT applicator): after removal from the patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Erasmus Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 29, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NL-011333

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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