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).
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
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
All patients referred for primary brachytherapy for cancer of the nasal vestibule in the participating institutes will be asked to participate.
Cohort
Prospective
Not listed
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-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
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.
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).
Patient satisfaction
Patient satisfaction measured using validated questionnaires filled in by the patients at baseline, 3 months, 12, 24 and 36 months (NAFEQ questionnaire).
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.
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Radboud University Medical Center
Lead sponsor
UMC Utrecht, Utrecht, the Netherlands
Collaborator
Amsterdam UMC
Collaborator
Erasmus Medical Center
Collaborator
Maastro Clinic, The Netherlands
Collaborator
San Giovanni Addolorata Hospital
Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Collaborator
The Greater Poland Cancer Centre
Collaborator
Saint John's Cancer Center of Lublin
Collaborator
Institut Català d'Oncologia
Collaborator
University of Navarra
Collaborator
University Hospital, Zürich
Collaborator
University Hospital Erlangen
Collaborator
University of Luebeck
Collaborator
Institut de Cancérologie de Lorraine
Collaborator
Atrys Health
Collaborator
Hospital Clínica Benidorm
Collaborator
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