Tests lower radiation doses for neck lymph nodes in head and neck cancer
Tests lower radiation doses and sentinel node mapping in head and neck cancer patients.
Plain-language title generated from the registry record
Registry title: Dose De-escalation and Sentinel LN Mapping Driven Radiotherapy of Contralateral Neck in Ipsilateral Node Positive HNSCC
Key facts
- Where
- Aalst, Brussels, Genk, Ghent, Hasselt, Leuven, Mechelen, Namur, and Turnhout, BelgiumSee the 10 sites
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with squamous cell cancer of the mouth, oropharynx, larynx or hypopharynx. Lymph nodes are affected on one side of the neck only, and radiotherapy is the planned main treatment.
- Age
- 18 years or older
- Sex
- All sexes
- Disease stage
- Proven invasive head and neck squamous cell cancer of the oral cavity, oropharynx, larynx or hypopharynx. Tumor stage T1 (except T1 of the glottis) to T4a. Lymph nodes affected only on the same side as the tumor (or one side for midline tumors). No distant metastasis.
- Earlier treatment
- The tumor board must have chosen radical radiotherapy, with or without chemotherapy, as the first treatment. No earlier radiotherapy or surgery in the neck that could change lymph drainage.
- Biomarker or test result
- HPV status does not matter for oropharynx tumors. Lymph nodes on the opposite side must look normal on CT or MRI and FDG-PET scans.
Main reasons for not taking part
- Cancer in the last five years (a few small skin or early cancers are allowed)
- Cancer of the nose, sinuses, oesophagus, salivary glands or nasopharynx
- Positive lymph nodes on the opposite side of the neck
- Distant metastasis or a second cancer at the same time
- Pregnant or breast-feeding, or able to have children without good contraception
Read by machine on 12 November 2026.
Where in Belgium
- OLV AalstAalst, BelgiumContact: Laurien De WaeleTaking people
- Institute Jules BordetBrussels, BelgiumContact: Clémence Al WardiTaking people
- UCL - Saint LucBrussels, BelgiumContact: Eléonore LongtonTaking people
- ZOLGenk, BelgiumContact: Liesbeth RaymakersTaking people
- University Hospital GentGhent, BelgiumContact: Frederic DuprezTaking people
- JESSA ZiekenhuisHasselt, BelgiumContact: Liesbeth RaymakersTaking people
- Universitaire Ziekenhuizen LeuvenLeuven, BelgiumContact: Chris BruyninckxTaking people
- AZ Sint MaartenMechelen, BelgiumContact: Julie van der VeenTaking people
- CHU UCL NamurNamur, BelgiumContact: Monique GilsoulTaking people
- AZ TurnhoutTurnhout, BelgiumContact: Nel BovinTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Universitaire Ziekenhuizen KU Leuven
- Trial code
- NCT04688528
- Record updated
- 1 July 2024
- Original description
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.Read full original descriptionShow less
A Prospective Randomized Phase 2 Study of Dose and Volume De-escalation Radiotherapy With Sentinel Lymph Nodes Mapping for Contralateral Irradiation in Unilaterally Node Positive Head and Neck Squamous Cell Carcinomas (SEMIRAHN)
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.
Inclusion: Written informed consent given according to ICH/GCP and national/local regulations must be obtained prior to any screening procedures; World Health Organization (WHO) performance status 0-1; Age ≥ 18 years; Patients with a pathologically proven invasive HNSCC, including oral cavity, oropharynx (independently of HPV status), larynx or hypopharynx; Decision by Multidisciplinary Tumor Board of primary treatment with radical radiotherapy with or without concurrent chemotherapy (according to the local guidelines); Baseline imaging of the neck:; ≤ 2.5 mm slices CT with iodine injection (independently or during the FDG-PET/CT examination IF acquired in normal diagnostic conditions, i.e. arms along the thorax with diagnostic quality); MRI not mandatory but allowed, performed according to centres guidelines; FDG-PET/CT; Tumor characteristics:; cT-classification (8th TNM staging): T1(except T1 of glottis)-T4a (or, for p16+ oropharyngeal tumors classified cT4, if criteria are compatible with cT4a-stage of p16- tumors); cN-classification (8th TNM staging), as assessed by iodine contrasted CT (or MRI) and FDG-PET:; i. mandatorily cN0 contralaterally to the primary tumor (or on one side of the neck for midline primary tumors):; 1. smallest diameter < 5 mm in retropharyngeal level (VIIa); 2. smallest diameter of Küttner node (level IIa) < 12 mm; 3. smallest diameter < 10 mm or sum of smallest and largest diameters < 17 mm in any other level; 4. no central necrosis ; 5. maximal standardized uptake value (SUVmax) ≤ 2.2; 6. in dubious cases (typically 2.2 < SUVmax < 4.5 and inconclusive CT or MRI), US-guided FNAC may be required to exclude positive node contralaterally; ii. ipsilaterally positive (if any of the above mentioned criteria is met), i.e. cN1, cN2a, cN2b, ipsilateral cN3b; or cN1 for oropharyngeal p16+ tumors; No distant metastasis.
Exclusion: Patient has history of:; radiotherapy or surgery in the neck with potential impact on lymphatic drainage ("violated neck"); cancer in the last five years (excluding skin basal cell carcinoma, in situ cervix carcinoma and T1 of glottis or lip, completely chirurgically resected (R0) without intervention disturbing cervical lymph drainage); Absolute contra-indication to iodine contrast injection, even after proper cortisone and cetirizine pre-medication; Synchronous second malignancy; Any psychological disorder or familial, sociological or geographical condition which, in the investigator's opinion, might jeopardise participant's safety or compliance with the protocol; Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method; Highly effective methods of birth control are defined as those, alone or in combination, that result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants, injectables, combined oral contraceptives, some IUDs, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatments) or vasectomised partner; HNSCC from nose, sinuses, oesophagus, salivary glands or nasopharynx; Non-HNSCC histology; Positive contralateral neck by node size or positive US-FNAC in dubious nodes; Distant metastasis; Tumor crossing the midline without contralateral mapping after 99mTc-nanocolloïd injection; Tumor too large to be safely injected, as deemed by the surgeon. In case of doubt, contact may always be taken with the national coordinating investigator to discuss the situation and take a final decision.