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. - PRIMO

Radboud Universitair Medisch Centrum0 个研究点目标入组 242 人开始时间: 待定最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•- Adult patients 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 PET/CT demonstrating
•- Recommendation for curative intent external beam (chemo)radiotherapy made by
•a multidisciplinary head and neck oncology team
•- Bilateral elective neck irradiation is indicated according to Dutch consensus
•guidelines (LPHHRT)
•- Procedures for sentinel lymph node biopsy are deemed feasible by the head and
•neck surgeon.

•- Recurrent disease or previous anticancer treatment to the head and neck area
•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 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.

发起方