CLEAR (Cervical Lymphatic Exclusion in Adjuvant Radiation)

NCT07755449 | Recruiting Phase 2

• 2 other identifiers: CLEARPR150/25
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Locally Advanced Head and Neck Squamous Cell Carcinoma

Keywords

squamous cell carcinoma; Head and neck cancer; elective nodal irradiation omission; radiotherapy de-escalation; Neck dissection

Outcome Measures

Primary Outcomes (1)

• Regional recurrence rate in non-irradiated cervical levels

  Rate to be compared to the recurrence rate reported with standard complete nodal irradiation (6-8%)

  At 24 months

Secondary Outcomes (8)

• Local and Regional Progression-Free Survival

  1 and 2 years

• Distant Metastasis-Free Survival

  1 and 2 years

• Overall Survival

  1 and 2 years

• Incidence of Acute and Chronic Toxicity

  3, 6, 12 and 24 months

• Quality of Life - European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)

  0, 6, 12, and 24 months

Study Arms (1)

Selective postoperative radiotherapy

EXPERIMENTAL

Postoperative IMRT or VMAT with selective cervical nodal irradiation based on pathological findings after neck dissection, omitting irradiation of low-risk cervical nodal levels.

Radiation: IMRT OR VMAT Radiotherapy excluding cervical radiation

Interventions

IMRT OR VMAT Radiotherapy excluding cervical radiation 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.

Selective postoperative radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Català d'Oncologia: lead

Study Sites (1)

Institut Català d'Oncologia

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

RECRUITING

MeSH Terms

Conditions

Carcinoma, Squamous Cell; Head and Neck Neoplasms

Interventions

Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Central Study Contacts

Isabel Linares

CONTACT

+34667129210; ilinaresgaliana@iconcologia.net

Paula Anglada

CONTACT

+34633685422; panglada@idibell.cat

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2026
• First Posted: August 10, 2026
• Study Start: July 13, 2026
• Primary Completion (Estimated): July 13, 2027
• Study Completion (Estimated): September 1, 2030
• Last Updated: August 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)