Personalized neck irradiation for head and neck cancer based on lymph node biopsy results
Personalized Elective 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. The PRIMO Study.
This study is testing if using biopsy results to personalize neck radiation can help people with laryngeal and pharyngeal cancer avoid unnecessary treatment and improve their quality of life.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 242 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Radboud University Medical Center Academic / other |
| Drugs / interventions | cetuximab, chemotherapy, radiation |
| Locations | 9 sites (Amsterdam and 8 other locations) |
| Trial ID | NCT05333523 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of sentinel lymph node biopsy to guide personalized elective neck irradiation in patients with laryngeal and pharyngeal squamous cell carcinoma. By accurately identifying patients with negative lymph nodes, the study aims to reduce unnecessary radiation exposure and its associated long-term side effects, such as xerostomia and dysphagia. The trial compares standard elective neck irradiation with a personalized approach based on biopsy results, potentially improving patient quality of life. The study is conducted in multiple leading medical centers in the Netherlands.
Who should consider this trial
Good fit: Ideal candidates are adults with newly diagnosed cT1-4N0M0 squamous cell carcinoma of the oropharynx, larynx, or hypopharynx.
Not a fit: Patients with recurrent disease or those who have previously undergone anticancer treatment to the head and neck area may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce radiation-related side effects for patients with head and neck cancer.
How similar studies have performed: Previous studies have shown promising results with sentinel lymph node biopsy in similar cancer types, indicating potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Amsterdam and 8 other locations
- The Netherlands Cancer Institute — Amsterdam, Netherlands (Recruiting)
- Radiotherapiegroep / Rijnstate Ziekenhuis — Arnhem, Netherlands (Not_yet_recruiting)
- Medisch Spectrum Twente (MST) — Enschede, Netherlands (Not_yet_recruiting)
- University Medical Center Groningen — Groningen, Netherlands (Recruiting)
- Leiden University Medical Center — Leiden, Netherlands (Recruiting)
- MAASTRO Clinic / Maastricht University Medical Center — Maastricht, Netherlands (Recruiting)
- Radboud University Nijmegen Medical Center — Nijmegen, Netherlands (Recruiting)
- Erasmus Medical Center — Rotterdam, Netherlands (Recruiting)
- University Medical Center Utrecht — Utrecht, Netherlands (Recruiting)
Study contacts
- Study coordinator: Dr. S. van den Bosch, MD, PhD
- Email: sven.vandenbosch@radboudumc.nl
- Phone: +31 (0) 24 361 45 15
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.