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Personalized neck irradiation guided by sentinel lymph node biopsy in patients with squamous cell carcinoma of the oropharynx, larynx or hypopharynx with a clinically negative neck: (Chemo)radiotherapy to the PRIMary tumor only. Protocol of the PRIMO study.
van den Bosch, S; Takes, R P; de Ridder, M; de Bree, R; Al-Mamgani, A; Schreuder, W H; Hoebers, F J P; van Weert, S; Elbers, J B W; Hardillo, J A; Meijer, T W H; Plaat, B E C; de Jong, M A; Jansen, J C; Wellenstein, D J; van den Broek, G B; Vogel, W V; Arens, A I J; Kaanders, J H A M.
Afiliación
  • van den Bosch S; Department of Radiation Oncology, Radboud University Medical Center, Nijmegen, The Netherlands.
  • Takes RP; Department of Otorhinolaryngology and Head and Neck Surgery, Radboud University Medical Center, Nijmegen, The Netherlands.
  • de Ridder M; Department of Radiation Oncology, University Medical Center Utrecht, Utrecht, The Netherlands.
  • de Bree R; Department of Head and Neck Surgical Oncology, University Medical Center Utrecht, Utrecht, The Netherlands.
  • Al-Mamgani A; Department of Radiation Oncology, Netherlands Cancer Institute/Antoni van Leeuwenhoek, Amsterdam, The Netherlands.
  • Schreuder WH; Department of Head and Neck Surgical Oncology, Netherlands Cancer Institute/Antoni van Leeuwenhoek, Amsterdam, The Netherlands.
  • Hoebers FJP; Department of Radiation Oncology (Maastro), Maastricht University Medical Center+, GROW-School for Oncology and Reproduction, Maastricht, The Netherlands.
  • van Weert S; Department of Otorhinolaryngology and Head and Neck Surgery, Maastricht University Medical Center+, Maastricht, The Netherlands.
  • Elbers JBW; Department of Radiation Oncology, Erasmus MC Cancer Centre, Rotterdam, The Netherlands.
  • Hardillo JA; Department of Otorhinolaryngology and Head and Neck Surgery, Erasmus MC Cancer Centre, Rotterdam, The Netherlands.
  • Meijer TWH; Department of Radiation Oncology, University Medical Center Groningen, Groningen, The Netherlands.
  • Plaat BEC; Department of Otorhinolaryngology and Head and Neck Surgery, University Medical Center Groningen, Groningen, The Netherlands.
  • de Jong MA; Department of Radiation Oncology, Leiden University Medical Center, Leiden, The Netherlands.
  • Jansen JC; Department of Otorhinolaryngology and Head and Neck Surgery, Leiden University Medical Center, Leiden, The Netherlands.
  • Wellenstein DJ; Department of Otorhinolaryngology and Head and Neck Surgery, Radboud University Medical Center, Nijmegen, The Netherlands.
  • van den Broek GB; Department of Otorhinolaryngology and Head and Neck Surgery, Radboud University Medical Center, Nijmegen, The Netherlands.
  • Vogel WV; Department of Medical Imaging/Department of Nuclear Medicine, Netherlands Cancer Institute/Antoni van Leeuwenhoek, Amsterdam, The Netherlands.
  • Arens AIJ; Department of Medical Imaging/Department of Nuclear Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.
  • Kaanders JHAM; Department of Radiation Oncology, Radboud University Medical Center, Nijmegen, The Netherlands.
Clin Transl Radiat Oncol ; 44: 100696, 2024 Jan.
Article en En | MEDLINE | ID: mdl-37965060
ABSTRACT

Background:

Elective neck irradiation (ENI) is performed in head and neck cancer patients treated with definitive (chemo)radiotherapy. The aim is to eradicate nodal metastases that are not detectable by pretreatment imaging techniques. It is conceivable that personalized neck irradiation can be performed guided by the results of sentinel lymph node biopsy (SLNB). It is expected that ENI can be omitted to one or both sides of the neck in 9 out of 10 patients, resulting in less radiation side effects with better quality of life. Methods/

design:

This is a multicenter randomized controlled trial aiming to compare safety and efficacy of treatment with SLNB guided neck irradiation versus standard bilateral ENI in 242 patients with cN0 squamous cell carcinoma of the oropharynx, larynx or hypopharynx for whom bilateral ENI is indicated. Patients randomized to the experimental-arm will undergo SLNB. Based on the histopathologic status of the SLNs, patients will receive no ENI (if all SLNs are negative), unilateral neck irradiation only (if a SLN is positive at one side of the neck) or bilateral neck irradiation (if SLNs are positive at both sides of the neck). Patients randomized to the control arm will not undergo SLNB but will receive standard bilateral ENI. The primary safety endpoint is the number of patients with recurrence in regional lymph nodes within 2 years after treatment. The primary efficacy endpoint is patient reported xerostomia-related quality of life at 6 months after treatment.

Discussion:

If this trial demonstrates that the experimental treatment is non-inferior to the standard treatment in terms of regional recurrence and is superior in terms of xerostomia-related quality of life, this will become the new standard of care.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Clin Transl Radiat Oncol Año: 2024 Tipo del documento: Article País de afiliación: Países Bajos Pais de publicación: Irlanda
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Clin Transl Radiat Oncol Año: 2024 Tipo del documento: Article País de afiliación: Países Bajos Pais de publicación: Irlanda