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

Launched by RADBOUD UNIVERSITY MEDICAL CENTER · Apr 11, 2022

Keywords

ClinConnect Summary

The PRIMO Study is a clinical trial designed to explore a personalized approach to treating certain types of throat cancers, specifically cancers of the oropharynx, larynx, and hypopharynx. The trial is looking at how using a special test called sentinel lymph node biopsy can help guide radiation treatment for patients with early-stage cancer that has not spread to nearby lymph nodes. This personalized treatment aims to improve outcomes while minimizing unnecessary radiation exposure to healthy tissues.

To participate in this study, patients need to be adults aged 18 or older who have recently been diagnosed with specific types of squamous cell carcinoma in their throat. They must also be in good overall health and have a clear imaging assessment showing no cancer spread to the lymph nodes. If eligible, participants can expect to receive personalized care from a team of cancer specialists and will be closely monitored throughout the treatment process. It's important to note that this trial is currently recruiting participants, so there is an opportunity for eligible patients to contribute to potentially important cancer research.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • Adult patients (≥18 years) with newly diagnosed cT1-4N0M0 squamous cell carcinoma of the oropharynx, larynx or hypopharynx.
• • Histopathological diagnosis of squamous cell carcinoma in the primary tumor.
• • Adequate staging of the neck including CT or MRI, and 18F-FDG-PET demonstrating cN0
• • 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 elective neck irradiation is indicated according to Dutch consensus guidelines (LPHHRT)
• • Procedures for sentinel lymph node biopsy (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 elective neck irradiation according to Dutch consensus guidelines (LPHHRT).
• • 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.