Status:
RECRUITING
Personalized Elective Neck Irradiation Guided by Sentinel Lymph Node Biopsy in Larynx and Pharynx Cancer. The PRIMO Study.
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
UMC Utrecht
The Netherlands Cancer Institute
Conditions:
Laryngeal Squamous Cell Carcinoma
Hypopharynx Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 pr...
Detailed Description
Rationale \| Squamous cell carcinoma of the upper aerodigestive tract comes with a substantial risk for cervical lymph node metastases. Elective neck irradiation is performed in patients receiving (ch...
Eligibility Criteria
Inclusion
- 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+) (AJCC TNM 8)
- Histopathological diagnosis of squamous cell carcinoma.
- Adequate staging of the neck including CT or MRI, and 18F-FDG-PET demonstrating no contralateral lymph node metastases.
- Recommendation for curative intent external beam (chemo)radiotherapy made by a multidisciplinary head and neck oncology team (in case of chemoradiotherapy, only patients receiving concomitant platinum-based regimen are eligible).
- Bilateral ENI is indicated according to Dutch consensus guidelines (LPHHRT) (see Appendix 13.1).
- Procedures for SLNB (i.e. tumor accessible for tracer injection, imaging and surgery under general anesthesia) are deemed feasible by the head and neck surgeon.
Exclusion
- Recurrent disease or previous anticancer treatment to the head and neck area (e.g. radical attempt or tumor reductive surgery, neck dissection, neo-adjuvant chemotherapy or radiotherapy) except for endoscopic glottic laser micro surgery.
- Well lateralized oropharyngeal cancers and early stage laryngeal cancers requiring no or unilateral ENI according to Dutch consensus guidelines (LPHHRT)
- Patients receiving concomitant non-platinum-based systemic agents (e.g. cetuximab).
- Patients that qualify for proton therapy and want to be treated accordingly.
- Compromised airway or tracheostomy.
- Any active invasive malignancy within the last 3 years except for early stage basal/squamous cell carcinoma of the skin and incidental finding of stage T1N0M0 prostate cancer.
- Any somatic, psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol or follow-up schedule.
Key Trial Info
Start Date :
December 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
242 Patients enrolled
Trial Details
Trial ID
NCT05333523
Start Date
December 6 2023
End Date
December 1 2029
Last Update
November 24 2025
Active Locations (9)
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1
The Netherlands Cancer Institute
Amsterdam, Netherlands
2
Radiotherapiegroep / Rijnstate Ziekenhuis
Arnhem, Netherlands
3
Medisch Spectrum Twente (MST)
Enschede, Netherlands
4
University Medical Center Groningen
Groningen, Netherlands