Skipping Neck Radiation After Surgery for Advanced Head and Neck Cancer
Tests leaving out neck radiation after surgery in head and neck squamous cell carcinoma.
Plain-language title generated from the registry record
Registry title: CLEAR (Cervical Lymphatic Exclusion in Adjuvant Radiation)
Key facts
- Where
- L'Hospitalet de Llobregat, SpainSee the site
- Phase
- Phase 2
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 who had surgery for advanced squamous cell cancer of the mouth, throat or voice box, with a neck dissection and no high-risk lymph node findings.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Locally advanced squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx; tumour and neck lymph nodes removed by surgery; stages pT1-pT2N1 and pT3-pT4N0/N1; at least 18 lymph nodes removed per neck; either no cancer in the lymph nodes (pN0) or a single cancerous node (pN1) with no spread beyond the node capsule, under 1 cm (0.4 in) and no skip metastasis
- Earlier treatment
- Must have had surgery to remove the primary tumour and a neck dissection. Cannot have had earlier radiotherapy or surgery in the head and neck region. Radiotherapy must start within 8 weeks of surgery.
Main reasons for not taking part
- No informed consent
- Earlier radiotherapy to the head and neck region
- Earlier surgery in the head and neck region
- Another cancer in the past 5 years (except non-melanoma skin cancer)
- More than 8 weeks between surgery and radiotherapy
Read by machine on 13 November 2026.
Where in Spain
- Institut Catala D'oncologiaL'Hospitalet de Llobregat, SpainContact: Isabel LinaresTaking 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
- Institut Català d'Oncologia
- Trial code
- NCT07755449
- Record updated
- 10 August 2026
- Original description
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:Read full original descriptionShow less
Phase II Clinical Trial to Evaluate the Exclusion of Cervical Volumes in Postoperative Irradiation of Locally Advanced Head and Neck Squamous Cell Carcinoma
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
Inclusion: 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: Prior irradiation to the head and neck region; Prior surgery in the head and neck region; Interval between surgery and radiotherapy > 8 weeks; History of malignancy within the previous 5 years, with the exception of non-melanoma skin cancer; Absence of informed consent; Contralateral neck dissection not performed when clinically indicated.