BRAVO
Sponsor study identifier
observational
300
1 country
1
Study Start
October 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
October 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
October 2034
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2034
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 26, 2026
Actual (reported)September 3, 2026
Actual (reported)October 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
October 2034
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
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
3 year
CTCAE toxicity scoring
3 years
Toxicity scoring by patients
3 years
Patient satisfaction
3 years
3-year regional and distant control
3 years
Overall survival
3 years
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)
All patients referred for primary brachytherapy for cancer of the nasal vestibule in the participating institutes will be asked to participate.
Radboud university medical center
Nijmegen, 6500HB, Netherlands
First Submitted
August 26, 2026
First Posted
September 3, 2026
Study Start
October 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
October 2029
EstimatedContact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
October 2034
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
September 3, 2026
Record last verified: 2026-08
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