Condition: Laryngeal Squamous Cell Carcinoma · Hypopharynx Squamous Cell Carcinoma · Oropharyngeal Squamous Cell Carcinoma · Sponsor: Radboud University Medical Center
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 pretreatment imaging techniques. It is conceivable that personalized neck irradiation can be performed guided by the results of sentinel lymph node biopsy. It is expected that elective neck irradiation can be omitted to one or both sides of the neck in 9 out of 10 patients with a clinically negative neck (cN0). For patients with clinically positive ipsilateral nodes (cN1-2b), it is expected that elective irradiation of the contralateral neck can be omitted in 7 out of 10 patients. This will enable better sparing of normal tissues from radiation and result in less permanent long-term radiation side effects with better quality of life. Methods/design \| This is a multicenter randomized controlled trial aiming to compare safety and efficacy of treatment with sentinel lymph node biopsy guided neck irradiation versus standard bilateral elective neck irradiation in 242 patients with cN0-N2b squamous cell carcinoma of the oropharynx, larynx or hypopharynx for whom bilateral elective neck irradiation is indicated. Patients randomized to the experimental-arm will undergo sentinel lymph node biopsy. Based on the histopathologic status of the sentinel lymph nodes, patients will receive no elective neck irradiation (if no nodal metastases found at both sides of the neck), unilateral neck irra…
This description comes directly from the study's public registry record.
Dr. S. van den Bosch, MD, PhD · +31 (0) 24 361 45 15 · sven.vandenbosch@radboudumc.nl
Prof. Dr. J.H.A.M. Kaanders, MD, PhD · +31 (0) 24 361 45 15 · j.kaanders@radboudumc.nl
Always discuss trial participation with your own doctor first.
| 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 |
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Source record: clinicaltrials.gov/study/NCT05333523