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Study identifier: NCT05333523 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Personalized Elective Neck Irradiation Guided by Sentinel Lymph Node Biopsy in Larynx and Pharynx Cancer. The PRIMO Study.

Condition: Laryngeal Squamous Cell Carcinoma · Hypopharynx Squamous Cell Carcinoma · Oropharyngeal Squamous Cell Carcinoma  ·  Sponsor: Radboud University Medical Center

PhasePhase 3
Planned participants242
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

Rationale \| Elective neck irradiation 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. It is expected that elective neck irradiation can be omitted to one or both sides of the neck in 9 out of 10 patients with a clinically negative neck (cN0). For patients with clinically positive ipsilateral nodes (cN1-2b), it is expected that elective irradiation of the contralateral neck can be omitted in 7 out of 10 patients. This will enable better sparing of normal tissues from radiation and result in less permanent long-term 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 sentinel lymph node biopsy guided neck irradiation versus standard bilateral elective neck irradiation in 242 patients with cN0-N2b squamous cell carcinoma of the oropharynx, larynx or hypopharynx for whom bilateral elective neck irradiation is indicated. Patients randomized to the experimental-arm will undergo sentinel lymph node biopsy. Based on the histopathologic status of the sentinel lymph nodes, patients will receive no elective neck irradiation (if no nodal metastases found at both sides of the neck), unilateral neck irra…

This description comes directly from the study's public registry record.

Talk to the study team

Dr. S. van den Bosch, MD, PhD  ·  +31 (0) 24 361 45 15  ·  sven.vandenbosch@radboudumc.nl

Prof. Dr. J.H.A.M. Kaanders, MD, PhD  ·  +31 (0) 24 361 45 15  ·  j.kaanders@radboudumc.nl

Always discuss trial participation with your own doctor first.

Locations (9)

The Netherlands Cancer InstituteAmsterdam, NetherlandsRecruiting
Radiotherapiegroep / Rijnstate ZiekenhuisArnhem, NetherlandsNot Yet Recruiting
Medisch Spectrum Twente (MST)Enschede, NetherlandsNot Yet Recruiting
University Medical Center GroningenGroningen, NetherlandsRecruiting
Leiden University Medical CenterLeiden, NetherlandsRecruiting
MAASTRO Clinic / Maastricht University Medical CenterMaastricht, NetherlandsRecruiting
Radboud University Nijmegen Medical CenterNijmegen, NetherlandsRecruiting
Erasmus Medical CenterRotterdam, NetherlandsRecruiting
University Medical Center UtrechtUtrecht, NetherlandsRecruiting

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Source record: clinicaltrials.gov/study/NCT05333523