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CLEAR (Cervical Lymphatic Exclusion in Adjuvant Radiation)
Sponsor: Institut Català d'Oncologia
Summary
The goal of this clinical trial is to learn if selectively omitting postoperative cervical irradiation is a safe and feasible treatment strategy for patients with resected, locally advanced squamous cell carcinoma of the head and neck (HNSCC) who underwent systematic neck dissection and have no high-risk nodal factors. The main questions it aims to answer are: * Is the regional recurrence rate with selective omission of postoperative cervical irradiation non-inferior to the recurrence rate reported with standard complete nodal irradiation (6-8%)? * Does selective omission of postoperative cervical irradiation reduce toxicity? * Does selective omission of postoperative cervical irradiation improve immunological preservation and quality of life? Researchers will compare outcomes in participants treated with this selective irradiation strategy to previously published data and to a retrospective institutional cohort treated with standard complete nodal irradiation, to see if it maintains regional control while reducing toxicity and preserving immune function and quality of life. Participants will: * Receive postoperative radiotherapy according to the new protocol, omitting irradiation of low-risk nodal levels * Receive concomitant chemotherapy if clinically indicated, per standard practice * Visit for checkups, blood sample collection, to complete quality-of-life questionnaires and attend follow-up visits over 48 months
Official title: Phase II Clinical Trial to Evaluate the Exclusion of Cervical Volumes in Postoperative Irradiation of Locally Advanced Head and Neck Squamous Cell Carcinoma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
101
Start Date
2026-07-13
Completion Date
2030-09-01
Last Updated
2026-08-10
Healthy Volunteers
No
Interventions
IMRT OR VMAT Radiotherapy excluding cervical radiation
30 or 33 sessions of radiotherapy 2 Gy sessions until 60 or 66 Gy will be administered to the primary tumor bed. Concomitant cisplatin chemotherapy may be administered per standard clinical practice in patients with high-risk primary tumor features (positive or close \[\<5 mm\] margins), when not clinically contraindicated.
Locations (1)
Institut Català d'Oncologia
L'Hospitalet de Llobregat, Barcelona, Spain