Locally Advanced Cervical CancerARCHITECTNCT07435987
Clinical Feasibility of the ARCHITECT Applicator in Cervical Cancer Brachytherapy
A study testing ARCHITECT applicator in people with Locally Advanced Cervical Cancer and Uterine Carcinoma, run by Erasmus Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Locally Advanced Cervical Cancer, Uterine Carcinoma
- What is being tested?
- ARCHITECT applicator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteNetherlands
- Study dates
- 22 Jul 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Locally advanced cervical cancer (FIGO 2018 stage 1B3-IVA) with indication for primary radiotherapy including brachytherapy
- Written informed consent
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus Medical Center
Rotterdam, 3015 GD
H. Westerveld, MD, PhD, +31 10 704 1249, g.westerveld@erasmusmc.nl
H. Westerveld, MD, PhD
About this study
Official title: 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.
Read the 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.
- Being tested
- ARCHITECT applicator
- Keywords
- Brachytherapy, Patient-tailored applicator, 3D-printed applicator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARCHITECT applicatorDevice
Patient-tailored, 3D-printed applicator
| Study group | Role | What they receive |
|---|---|---|
| Study arm | Experimental | 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. Receives: Device: ARCHITECT applicator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical feasibility
To deliver brachytherapy using the patient-tailored, 3D printed ARCHITECT applicator [yes/no]
Measured: At week 2 (ARCHITECT applicator)
Secondary outcomes (7)
Brachytherapy-related adverse events
Organ perforation, vaginal bleeding, and device-related infection according to the common terminology criteria for adverse events (CTCAE) version 5
Measured: 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]
Measured: 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]
Measured: 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.
Measured: At week 1 (standard applicator) and 2 (ARCHITECT applicator)
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]
Measured: 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"
Measured: 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].
Measured: At week 2 (ARCHITECT applicator): after removal from the patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start22 Jul 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Locally Advanced Cervical CancerStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. G.H. (Henrike) Westerveld, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07435987
- Sponsor's protocol ID
- NL-011333
- Acronym
- ARCHITECT
- Status last verified
- Sep 2026
- First submitted
- 29 Jan 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 39447602
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Feasibility of the ARCHITECT Applicator in High-dose-rate Cervical Cancer Brachytherapy
- ClinicalTrials.gov ID
- NCT07435987
- Acronym / sponsor ID
- ARCHITECT / NL-011333
- Keywords
- Brachytherapy, Patient-tailored applicator, 3D-printed applicator
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 22 Jul 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Study arm | Experimental | Device: ARCHITECT applicatorIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Locally advanced cervical cancer (FIGO 2018 stage 1B3-IVA) with indication for primary radiotherapy including brachytherapy
- Written informed consent
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARCHITECT applicatorPatient-tailored, 3D-printed applicator | Device | Study arm |
Primary outcome
Clinical feasibility
Time frame: At week 2 (ARCHITECT applicator)
To deliver brachytherapy using the patient-tailored, 3D printed ARCHITECT applicator [yes/no]
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Background: PubMed 39447602Straathof 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ARCHITECT applicator in people with Locally Advanced Cervical Cancer and Uterine Carcinoma, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact H. Westerveld, MD, PhD (+31 10 704 1249, g.westerveld@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical feasibility (time frame: At week 2 (ARCHITECT applicator)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07435987, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.