Personalized neck irradiation for head and neck cancer based on lymph node biopsy results

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• The Netherlands Cancer Institute
  Amsterdam, Netherlands 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

Study contacts

• Study coordinator: Dr. S. van den Bosch, MD, PhD
• Email: sven.vandenbosch@radboudumc.nl
• Phone: +31 (0) 24 361 45 15

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.