242
Participants
Start Date
November 10, 2023
Primary Completion Date
December 1, 2028
Study Completion Date
December 1, 2028
Sentinel lymph node biopsy guided selective elective neck irradiation
"Patients will undergo sentinel lymph node biopsy. Based on the histopathologic status of the sentinel lymph node(s), selective elective neck irradiation is performed with standard radiation treatment of the primary tumor.~There are 3 possible treatment scenarios.~1. Bilateral elective neck irradiation is indicated when sentinel lymph nodes at both sides of the neck contain metastases or when sentinel lymph node detection fails.~2. Unilateral elective neck irradiation is indicated when sentinel lymph node(s) at one side of the neck contain metastases.~3. Full omission of elective neck irradiation is indicated when all sentinel lymph nodes are free of metastases."
Standard elective neck irradiation
Patients randomized to the control arm will receive the standard of care, according to (inter)national clinical practice guidelines. This will consist of (chemo)radiotherapy to the primary tumor with standard elective neck irradiation in all patients. No sentinel lymph node biopsy will be performed.
NOT_YET_RECRUITING
The Netherlands Cancer Institute, Amsterdam
NOT_YET_RECRUITING
University Medical Center Groningen, Groningen
NOT_YET_RECRUITING
Leiden University Medical Center, Leiden
NOT_YET_RECRUITING
Maastricht University Medical Center, Maastricht
NOT_YET_RECRUITING
MAASTRO Clinic, Maastricht
RECRUITING
Radboud University Nijmegen Medical Center, Nijmegen
NOT_YET_RECRUITING
Erasmus Medical Center, Rotterdam
RECRUITING
University Medical Center Utrecht, Utrecht
Collaborators (1)
UMC Utrecht
OTHER
The Netherlands Cancer Institute
OTHER
Erasmus Medical Center
OTHER
Leiden University Medical Center
OTHER
Maastro Clinic, The Netherlands
OTHER
Maastricht University Medical Center
OTHER
University Medical Center Groningen
OTHER
Radboud University Medical Center
OTHER