RecruitingNot ApplicableNCT04688528

Dose De-escalation and Sentinel LN Mapping Driven Radiotherapy of Contralateral Neck in Ipsilateral Node Positive HNSCC

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)

Sponsor

Universitaire Ziekenhuizen KU Leuven

Enrollment

147 participants

Start Date

Jun 10, 2021

Study Type

INTERVENTIONAL

Conditions

Squamous Cell Carcinoma of Head and Neck

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether it is safe to reduce radiation to the opposite (contralateral) side of the neck in head and neck cancer patients whose cancer is only on one side, by using sentinel lymph node mapping to confirm there are no cancer cells on that side. The goal is to reduce radiation side effects. **You may be eligible if...** - You are 18 or older - You have confirmed head and neck squamous cell carcinoma (mouth, throat, voice box, or hypopharynx) - Your cancer involves lymph nodes on one side of the neck only - Your treatment plan involves radiation with or without chemotherapy with curative intent - Your imaging meets the study's quality requirements **You may NOT be eligible if...** - Your cancer has spread to both sides of the neck - You are not medically fit for radical radiotherapy - Your tumor does not meet the site or staging requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONDose de-escalation and / or Volume de-escalation

The dose de-escalation and/or volume de-escalation strategy will be individually adapted in function of the draining pattern of sentinel lymph nodes on the contralateral side of the neck.