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

PHASE3RecruitingINTERVENTIONAL
Enrollment

242

Participants

Timeline

Start Date

November 10, 2023

Primary Completion Date

December 1, 2028

Study Completion Date

December 1, 2028

Conditions
Laryngeal Squamous Cell CarcinomaHypopharynx Squamous Cell CarcinomaOropharyngeal Squamous Cell Carcinoma
Interventions
RADIATION

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."

RADIATION

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.

Trial Locations (8)

Unknown

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

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

UMC Utrecht

OTHER

collaborator

The Netherlands Cancer Institute

OTHER

collaborator

Erasmus Medical Center

OTHER

collaborator

Leiden University Medical Center

OTHER

collaborator

Maastro Clinic, The Netherlands

OTHER

collaborator

Maastricht University Medical Center

OTHER

collaborator

University Medical Center Groningen

OTHER

lead

Radboud University Medical Center

OTHER