NCT07755449RecruitingPhase 2

CLEAR (Cervical Lymphatic Exclusion in Adjuvant Radiation)

Phase II Clinical Trial to Evaluate the Exclusion of Cervical Volumes in Postoperative Irradiation of Locally Advanced Head and Neck Squamous Cell Carcinoma

Source: ClinicalTrials.gov · Last updated 10 Aug 2026

Brief summary (registry, in English)

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

Status (registry): Recruiting
Phase (registry): Phase 2
Study type: Interventional
Enrollment: 101 (estimated)
First submitted: 30 Jul 2026
Start date: 13 Jul 2026
Primary completion date: 13 Jul 2027
Lead sponsor: Institut Català d'Oncologia
Diseases: Head and neck cancer
NCT number: NCT07755449

What you commit to

Study type: Interventional · Phase 2
Planned participants: 101
From 13 Jul 2026 to the primary completion date, 13 Jul 2027
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Prior irradiation to the head and neck region
Prior surgery in the head and neck region
Interval between surgery and radiotherapy \> 8 weeks

Other illness

History of malignancy within the previous 5 years, with the exception of non-melanoma skin cancer

Other

Absence of informed consent
Contralateral neck dissection not performed when clinically indicated

Who the study is looking for

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)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Institut Catala D'oncologia Coordinator of this site? Confirm its status	L'Hospitalet de Llobregat	Spain	Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.