CLEAR (Cervical Lymphatic Exclusion in Adjuvant Radiation)
Spain101 participantsStarted 2026-07-13
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients ≥ 18 years of age
* ECOG Performance Status (PS) ≤ 2
* Histologically confirmed diagnosis of locally advanced squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx
* Resection of the primary tumor and unilateral and/or bilateral neck dissection performed according to standard guidelines, with detailed histological reporting by nodal level
* Number of lymph nodes per dissected neck ≥ 18
* No pathological lymph nodes following neck dissection (pN0)
* Presence of a single pathological cervical lymph node following neck dissection (pN1), provided that:
* No extracapsular extension
* Diameter \< 1 cm
* No skip metastasis
* Presence of risk factors indicating postoperative radiotherapy. Stages pT1-pT2N1 and pT3-pT4N0/N1. If N1, all of the following criteria must be met: presence of a single cervical lymph node without extracapsular extension, diameter \< 1 cm, and no skip metastasis
* Patients may receive adjuvant systemic treatment if surgical margins are positive or close (\< 5 mm)
Exclusion Criteria:
* Absence of informed consent
* Prior irradiation to the head and neck region
* Prior surgery in the head and neck region
* Contralateral neck dissection not performed when clinically indicated
* History of malignancy within the previous 5 years, with the exception of non-melanoma skin cancer
* Interval between surgery and radiotherapy \> 8 weeks
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Regional recurrence rate in non-irradiated cervical levels