Actively Recruiting
Personalized Elective Neck Irradiation Guided by Sentinel Lymph Node Biopsy in Larynx and Pharynx Cancer. The PRIMO Study.
Led by Radboud University Medical Center · Updated on 2025-11-24
242
Participants Needed
9
Research Sites
312 weeks
Total Duration
On this page
Sponsors
R
Radboud University Medical Center
Lead Sponsor
U
UMC Utrecht
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 irradiation only (if no nodal metastases found at contralateral side of the neck only) or bilateral neck irradiation (if nodal metastases found at both sides of the neck). Patients randomized to the control arm will not undergo sentinel lymph node biopsy but will receive standard bilateral elective neck irradiation. 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.
CONDITIONS
Official Title
Personalized Elective Neck Irradiation Guided by Sentinel Lymph Node Biopsy in Larynx and Pharynx Cancer. The PRIMO Study.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients (≥18 years) with newly diagnosed cT1-4N0-2bM0 squamous cell carcinoma of the oropharynx (HPV-), larynx or hypopharynx, or cT1-4N0-1M0 oropharynx (HPV+)
- Histopathological diagnosis of squamous cell carcinoma
- Adequate neck staging including CT or MRI and 18F-FDG-PET showing no contralateral lymph node metastases
- Recommended for curative intent external beam (chemo)radiotherapy by a multidisciplinary head and neck oncology team
- Bilateral elective neck irradiation indicated according to Dutch consensus guidelines
- Procedures for sentinel lymph node biopsy deemed feasible by the head and neck surgeon
You will not qualify if you...
- Recurrent disease or previous anticancer treatment to head and neck except endoscopic glottic laser micro surgery
- Well lateralized oropharyngeal cancers and early stage laryngeal cancers requiring no or unilateral elective neck irradiation
- Receiving concomitant non-platinum-based systemic agents (e.g. cetuximab)
- Eligible for proton therapy and choosing that treatment
- Compromised airway or tracheostomy
- Any active invasive malignancy within last 3 years except early stage basal/squamous cell skin cancer and incidental stage T1N0M0 prostate cancer
- Any condition potentially hampering compliance with study protocol or follow-up schedule
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
The Netherlands Cancer Institute
Amsterdam, Netherlands
Actively Recruiting
2
Radiotherapiegroep / Rijnstate Ziekenhuis
Arnhem, Netherlands
Not Yet Recruiting
3
Medisch Spectrum Twente (MST)
Enschede, Netherlands
Not Yet Recruiting
4
University Medical Center Groningen
Groningen, Netherlands
Actively Recruiting
5
Leiden University Medical Center
Leiden, Netherlands
Actively Recruiting
6
MAASTRO Clinic / Maastricht University Medical Center
Maastricht, Netherlands
Actively Recruiting
7
Radboud University Nijmegen Medical Center
Nijmegen, Netherlands
Actively Recruiting
8
Erasmus Medical Center
Rotterdam, Netherlands
Actively Recruiting
9
University Medical Center Utrecht
Utrecht, Netherlands
Actively Recruiting
Research Team
D
Dr. S. van den Bosch, MD, PhD
CONTACT
P
Prof. Dr. J.H.A.M. Kaanders, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here