Carcinoma Nasal VestibuleBRAVONCT07801690
Brachytherapy (Interventional Radiotherapy) for Squamous Cell Carcinomas of the Nasal Vestibule: Optimization of Dose and Technique
An observational study of Carcinoma Nasal Vestibule, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Rationale: Primary brachytherapy (also known as Interventional Radiotherapy, IRT) achieves high cure rates in cancer of the nasal vestibule (CNV) while preserving nasal aesthetics and function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma Nasal Vestibule
- How many people
- 300 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Oct 2026to Oct 2034
- Phase
- Observational
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients referred for primary brachytherapy for cancer of the nasal vestibule in the participating institutes will be asked to participate.
Who may be able to join
- Aged 18 years or older
- Rome stage 1-4 / Wang Stage T1 -T3
- Staging of the neck by ultrasound/FNAC and/or (FDG-PET)CT and/or MRI is performed
- Brachytherapy with curative intent as sole treatment for the primary tumor
- Suitable to undergo brachy procedure, based on clinical judgment
Who cannot join
- Other primary tumor, except bcc skin or curatively treated cancer > 3 years before inclusion
- Previous radiotherapy to the treated area
- Distant metastasis
- Inability to comply with study procedures, including filling out treatment related questionnaires and to comply with scheduled follow-up visits
- Non-squamous cell histology
- Combinations with systemic therapy
- Combination to EBRT and brachytherapy to primary tumor
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
Radboud university medical center
Nijmegen, 6500HB
Casper Reijnen, MD, PhD, 0031243614505, casper.reijnen@radboudumc.nl
About this study
Official title: Brachytherapy (Interventional Radiotherapy) for Squamous Cell Carcinomas of the Nasal Vestibule: Optimization of Dose and Technique A Multicenter Prospective Registration Study Endorsed by HNS GEC-ESTRO WG
Rationale: Primary brachytherapy (also known as Interventional Radiotherapy, IRT) achieves high cure rates in cancer of the nasal vestibule (CNV) while preserving nasal aesthetics and function. In our recently published nationwide multicenter study, brachytherapy (BT) increased nose preservation probability from 61 to 82 % compared to external beam radiotherapy (EBRT). Although late toxicity was more common following BT, it was predominantly CTCAE grade 1-2 and deemed acceptable given the substantial benefit in local control and nose preservation.
However, a notable finding of our study was the substantial variation in BT practice, including implantation techniques, dose prescriptions, and treatment planning. Although this analysis covers one of the largest series of CNV patients to date, patient numbers were insufficient to reliably compare the efficacy of the different application/implantation techniques and doses. The retrospective design of the study proved inappropriate for a detailed analysis of the dose-volume data, which is necessary to correlate implantation and dose data to outcome. As the integral brachytherapy dose, as well as the dose inhomogeneity in tissue may vary widely depending on how the dose is prescribed, simple prescription doses are insufficient to characterize a brachytherapy plan comprehensively.
Read more
Given the excellent disease control achieved with BT, optimizing aesthetic and functional outcomes while minimizing toxicity becomes increasingly important. Therefore, to optimize BT treatment for CNV and facilitate its wider adoption, detailed prospective data collection on treatment parameters, dose plans, toxicity (both physician-reported and patient-reported), oncological outcomes, and functional results is necessary. This study is designed as a non-comparative, descriptive prospective registry aimed at systematically documenting current international practice in brachytherapy for cancer of the nasal vestibule.
Objective: To prospectively describe BT treatment techniques, parameters, oncological outcomes, acute and late toxicity and patient satisfaction; and to correlate these outcomes with treatment parameters. Specifically, to establish dose-response relationships for oncological control, toxicity, and functional outcomes.
Study design: Prospective observational multicentre registration study. Study population: Adults with a squamous cell squamous cell carcinoma of the nasal vestibule, considered suitable for primary brachytherapy.
Main study parameters/endpoints: To describe treatment techniques, dose prescriptions and brachytherapy dose plans in terms of dose-volume parameters. Oncological outcomes include details on recurrence and cancer-specific survival. Toxicity, patient satisfaction, and QoL will be assessed with validated patient questionnaires as through applicable CTCAE (physician based).
- Conditions
- Carcinoma Nasal Vestibule
- Keywords
- brachytherapy, interventional radiotherapy, carcinoma nasal vestibule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ll patients referred for primary brachytherapy for cancer of the nasal vestibule | Newly diagnosed CNV patients, eligible according to the study in- and exclusion criteria. Patients will receive the same treatment and have the same follow-up as patients who do not participate in the study. Eligible patients will be asked to consent to the use of their tumor- and treatment data for the purpose of the study and to fill out QoL- and functional and cosmetic evaluation questionnaires at pre-specified timepoints at start of, during, and after treatment. Recruitment will be organized through the treating physician, who will obtain written informed consent, given according to standard research procedures. Patients will be accrued from participating institutions, recruited from the Dutch Head\& Neck Cancer Working Party and the GEC-ESTRO H\&N brachy workgroup (Groupe Européen de Curiethérapie and the European Society for Radiation Therapy and Oncology) |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year local disease control
The primary endpoint is 3-year local disease control, defined as absence of histologically or radiologically confirmed local recurrence within the treated nasal vestibule region, measured from start of brachytherapy until recurrence or last follow-up.
Measured: 3 years
3-year freedom from (partial) nose amputation
The second primary endpoint is 3-year freedom from (partial) nose amputation, defined as absence of histologically or radiologically confirmed local recurrence requiring (partial) removal of the nose, measured from start of brachytherapy until recurrence or last follow-up
Measured: 3 year
Secondary outcomes (6)
CTCAE toxicity scoring
CTCAE 5.0 toxicity scoring for skin, mucosa, septum (cartilage) assessed at baseline, end of treatment, 3 months, 6 months and annually up to three years after treatment. These will be assessed by the treating physician during clinical follow-up visits.
Measured: 3 years
Toxicity scoring by patients
Pain, dryness/mucous secretion , nasal bleeding , nasal occlusion, synechiae, loss of smell/taste (applicable PRO-CTCAE components: anosmia, dysgeusia, pain, rhinorrhea, skin hyper/hypopigmentation).
Measured: 3 years
Patient satisfaction
Patient satisfaction measured using validated questionnaires filled in by the patients at baseline, 3 months, 12, 24 and 36 months (NAFEQ questionnaire).
Measured: 3 years
3-year regional and distant control
Defined as absence of histologically or radiologically confirmed regional recurrence (regional lymph node metastasis) or distant recurrence within the treated nasal vestibule region, measured from start of brachytherapy until recurrence or last follow-up.
Measured: 3 years
Overall survival
measured from start of brachytherapy until recurrence or last follow-up
Measured: 3 years
Patient satisfaction (2)
Patient satisfaction measured using validated questionnaires filled in by the patients at baseline, 3 months, 12, 24 and 36 months (ROE questionnaire).
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completionOct 2029 (estimated)
- Study completionOct 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma Nasal VestibuleStudies of the same condition, open and under way.
- More trials run by Radboud University 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- UMC Utrecht, Utrecht, the Netherlands, Amsterdam UMC, Erasmus Medical Center, Maastro Clinic, The Netherlands, San Giovanni Addolorata Hospital, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, The Greater Poland Cancer Centre, Saint John's Cancer Center of Lublin, Institut Català d'Oncologia, University of Navarra, University Hospital, Zürich, University Hospital Erlangen, University of Luebeck, Institut de Cancérologie de Lorraine, Atrys Health, Hospital Clínica Benidorm
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07801690
- Sponsor's protocol ID
- 2026-19203
- Acronym
- BRAVO
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brachytherapy (Interventional Radiotherapy) for Squamous Cell Carcinomas of the Nasal Vestibule: Optimization of Dose and Technique A Multicenter Prospective Registration Study Endorsed by HNS GEC-ESTRO WG
- ClinicalTrials.gov ID
- NCT07801690
- Acronym / sponsor ID
- BRAVO / 2026-19203
- Conditions
- Carcinoma Nasal Vestibule
- Keywords
- brachytherapy, interventional radiotherapy, carcinoma nasal vestibule
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- UMC Utrecht, Utrecht, the Netherlands, Amsterdam UMC, Erasmus Medical Center, Maastro Clinic, The Netherlands, San Giovanni Addolorata Hospital, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, The Greater Poland Cancer Centre, Saint John's Cancer Center of Lublin, Institut Català d'Oncologia, University of Navarra, University Hospital, Zürich, University Hospital Erlangen, University of Luebeck, Institut de Cancérologie de Lorraine, Atrys Health, Hospital Clínica Benidorm
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- Oct 2029 (estimated)
- Study completion
- Oct 2034 (estimated)
- First posted
- 3 Sep 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.
Rationale: Primary brachytherapy (also known as Interventional Radiotherapy, IRT) achieves high cure rates in cancer of the nasal vestibule (CNV) while preserving nasal aesthetics and function. In our recently published nationwide multicenter study, brachytherapy (BT) increased nose preservation probability from 61 to 82 % compared to external beam radiotherapy (EBRT). Although late toxicity was more common following BT, it was predominantly CTCAE grade 1-2 and deemed acceptable given the substantial benefit in local control and nose preservation.
However, a notable finding of our study was the substantial variation in BT practice, including implantation techniques, dose prescriptions, and treatment planning. Although this analysis covers one of the largest series of CNV patients to date, patient numbers were insufficient to reliably compare the efficacy of the different application/implantation techniques and doses. The retrospective design of the study proved inappropriate for a detailed analysis of the dose-volume data, which is necessary to correlate implantation and dose data to outcome. As the integral brachytherapy dose, as well as the dose inhomogeneity in tissue may vary widely depending on how the dose is prescribed, simple prescription doses are insufficient to characterize a brachytherapy plan comprehensively.
Given the excellent disease control achieved with BT, optimizing aesthetic and functional outcomes while minimizing toxicity becomes increasingly important. Therefore, to optimize BT treatment for CNV and facilitate its wider adoption, detailed prospective data collection on treatment parameters, dose plans, toxicity (both physician-reported and patient-reported), oncological outcomes, and functional results is necessary. This study is designed as a non-comparative, descriptive prospective registry aimed at systematically documenting current international practice in brachytherapy for cancer of the nasal vestibule.
Objective: To prospectively describe BT treatment techniques, parameters, oncological outcomes, acute and late toxicity and patient satisfaction; and to correlate these outcomes with treatment parameters. Specifically, to establish dose-response relationships for oncological control, toxicity, and functional outcomes.
Study design: Prospective observational multicentre registration study. Study population: Adults with a squamous cell squamous cell carcinoma of the nasal vestibule, considered suitable for primary brachytherapy.
Main study parameters/endpoints: To describe treatment techniques, dose prescriptions and brachytherapy dose plans in terms of dose-volume parameters. Oncological outcomes include details on recurrence and cancer-specific survival. Toxicity, patient satisfaction, and QoL will be assessed with validated patient questionnaires as through applicable CTCAE (physician based).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ll patients referred for primary brachytherapy for cancer of the nasal vestibule | – | –Newly diagnosed CNV patients, eligible according to the study in- and exclusion criteria. Patients will receive the same treatment and have the same follow-up as patients who do not participate in the study. Eligible patients will be asked to consent to the use of their tumor- and treatment data for the purpose of the study and to fill out QoL- and functional and cosmetic evaluation questionnaires at pre-specified timepoints at start of, during, and after treatment. Recruitment will be organized through the treating physician, who will obtain written informed consent, given according to standard research procedures. Patients will be accrued from participating institutions, recruited from the Dutch Head\& Neck Cancer Working Party and the GEC-ESTRO H\&N brachy workgroup (Groupe Européen de Curiethérapie and the European Society for Radiation Therapy and Oncology) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients referred for primary brachytherapy for cancer of the nasal vestibule in the participating institutes will be asked to participate.
Key inclusion criteria (5 listed)
- Aged 18 years or older
- Rome stage 1-4 / Wang Stage T1 -T3
- Staging of the neck by ultrasound/FNAC and/or (FDG-PET)CT and/or MRI is performed
- Brachytherapy with curative intent as sole treatment for the primary tumor
- Suitable to undergo brachy procedure, based on clinical judgment
Key exclusion criteria (7 listed)
- Other primary tumor, except bcc skin or curatively treated cancer > 3 years before inclusion
- Previous radiotherapy to the treated area
- Distant metastasis
- Inability to comply with study procedures, including filling out treatment related questionnaires and to comply with scheduled follow-up visits
- Non-squamous cell histology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
3-year local disease control
Time frame: 3 years
The primary endpoint is 3-year local disease control, defined as absence of histologically or radiologically confirmed local recurrence within the treated nasal vestibule region, measured from start of brachytherapy until recurrence or last follow-up.
3-year freedom from (partial) nose amputation
Time frame: 3 year
The second primary endpoint is 3-year freedom from (partial) nose amputation, defined as absence of histologically or radiologically confirmed local recurrence requiring (partial) removal of the nose, measured from start of brachytherapy until recurrence or last follow-up
6 secondary outcomes
CTCAE toxicity scoring
Time frame: 3 years
Toxicity scoring by patients
Time frame: 3 years
Patient satisfaction
Time frame: 3 years
3-year regional and distant control
Time frame: 3 years
Overall survival
Time frame: 3 years
Patient satisfaction (2)
Time frame: 3 years
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 3 Sep 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Carcinoma Nasal Vestibule
RecruitingObservational study
Survival and Prognostic Factors of Squamous Cell Carcinoma of the Nasal Vestibule
Nasal Vestibule Carcinoma, Rhinectomy
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?
An observational study of Carcinoma Nasal Vestibule, run by Radboud University 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 5 inclusion and 7 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: opening soon, as of the sponsor's last update on 3 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 Casper Reijnen, MD, PhD (0031243614505, casper.reijnen@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year local disease control (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Sep 2026.