Actively Recruiting
Dose De-escalation and Sentinel LN Mapping Driven Radiotherapy of Contralateral Neck in Ipsilateral Node Positive HNSCC
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2024-07-01
147
Participants Needed
10
Research Sites
290 weeks
Total Duration
On this page
Sponsors
U
Universitaire Ziekenhuizen KU Leuven
Lead Sponsor
S
Stichting tegen Kanker
Collaborating Sponsor
AI-Summary
What this Trial Is About
The study involves head and neck squamous cell carcinomas (HNSCC) of the oral cavity, oropharynx, larynx or hypopharynx with positive nodes on only one side of the neck and no distant metastasis treated by primary (chemo)radiotherapy. The elective node irradiation on the contralateral side is not always mandatory and the dose may be too high. In this study, we evaluate two strategies: the impact of sentinel lymph node mapping to tailor the volumes to irradiate and the dose reduction.
CONDITIONS
Official Title
Dose De-escalation and Sentinel LN Mapping Driven Radiotherapy of Contralateral Neck in Ipsilateral Node Positive HNSCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent obtained before any screening procedures.
- World Health Organization (WHO) performance status of 0 or 1.
- Age 18 years or older.
- Pathologically confirmed invasive head and neck squamous cell carcinoma in oral cavity, oropharynx (any HPV status), larynx, or hypopharynx.
- Multidisciplinary Tumor Board decision for primary treatment with radical radiotherapy with or without chemotherapy.
- Baseline neck imaging including CT with iodine injection, optional MRI, and FDG-PET/CT.
- Tumor staging: cT1 (except glottis T1) to T4a, or cT4 for p16+ oropharyngeal tumors if compatible with cT4a of p16- tumors.
- Contralateral neck classified as cN0 by imaging criteria, ipsilateral nodes classified as cN1, cN2a, cN2b, or cN3b.
- No distant metastasis.
You will not qualify if you...
- History of neck radiotherapy or surgery affecting lymphatic drainage.
- Cancer in the last five years except certain skin, cervix, or early glottis/lip cancers fully resected without lymph drainage impact.
- Absolute contraindication to iodine contrast injection.
- HNSCC originating from nose, sinuses, esophagus, salivary glands, or nasopharynx.
- Non-squamous cell carcinoma histology.
- Positive contralateral neck nodes by size or biopsy.
- Synchronous second malignancy.
- Presence of distant metastasis.
- Tumor crossing midline without contralateral mapping after tracer injection.
- Tumor too large for safe injection as judged by surgeon.
- Psychological, familial, sociological, or geographical issues that may affect safety or protocol compliance.
- Female who is pregnant, breastfeeding, or not using effective contraception if of childbearing potential.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
ZOL
Genk, Limburg, Belgium, 3600
Actively Recruiting
2
Jessa Ziekenhuis
Hasselt, Limburg, Belgium, 3500
Actively Recruiting
3
OLV Aalst
Aalst, Belgium, 9300
Actively Recruiting
4
UCL Saint-Luc
Brussels, Belgium, 1200
Actively Recruiting
5
Institute Jules Bordet
Brussels, Belgium
Actively Recruiting
6
University Hospital Gent
Ghent, Belgium
Actively Recruiting
7
Universitaire Ziekenhuizen Leuven
Leuven, Belgium, 3000
Actively Recruiting
8
AZ Sint-Maarten
Mechelen, Belgium, 2800
Actively Recruiting
9
CHU-UCL Namur
Namur, Belgium
Actively Recruiting
10
AZ Turnhout
Turnhout, Belgium, 2300
Actively Recruiting
Research Team
J
Jean-François Daisne, MD, PhD
CONTACT
C
Chris Bruyninckx, BA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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