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NCT Number: NCT07755449

CLEAR (Cervical Lymphatic Exclusion in Adjuvant Radiation)

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

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Key information

Conditions

Locally Advanced Head and Neck Squamous Cell Carcinoma Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Institut Català d'Oncologia

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Regional recurrence rate in non-irradiated cervical levels

    Time frame: At 24 months

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

Secondary outcomes

  1. Local and Regional Progression-Free Survival

    Time frame: 1 and 2 years

    Will be estimated using the Kaplan-Meier method, assessed in both the intention-to-treat and per-protocol populations, with the per-protocol population as the basis for the final analysis.

  2. Distant Metastasis-Free Survival

    Time frame: 1 and 2 years

    Distant metastasis-free survival will be estimated using the Kaplan-Meier method, assessed in both the intention-to-treat and per-protocol populations, with the per-protocol population as the basis for the final analysis.

  3. Overall Survival

    Time frame: 1 and 2 years

    will be estimated using the Kaplan-Meier method, assessed in both the intention-to-treat and per-protocol populations, with the per-protocol population as the basis for the final analysis

  4. Incidence of Acute and Chronic Toxicity

    Time frame: 3, 6, 12 and 24 months

    Will be assessed using CTCAE v5.0. Cumulative incidence will be analyzed by grade and affected organ/system along with prevalence, in the safety population.

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

    Time frame: 0, 6, 12, and 24 months

    Quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) at each time point compared with baseline in the intention-to-treat population. The questionnaire employs 28 items rated on 4-point Likert scales and two items rated on 7-point Likert scales, with response options ranging from "Not at all" to "Very much" and from "Very poor" to "Excellent", respectively. Scores are linearly transformed to a 0-100 scale. For the functional scales and the Global Health Status/Quality of Life scale, higher scores indicate better functioning or quality of life, whereas for the symptom scales, higher scores indicate greater symptom burden.

  6. Quality of Life - European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck 35 (EORTC QLQ-H&N35)

    Time frame: 0, 6, 12, and 24 months

    Quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck 35 (EORTC QLQ-H&N35) at each time point compared with baseline in the intention-to-treat population. The questionnaire employs 30 items rated on 4-point Likert scales, with response options ranging from "Not at all" to "Very much", and five dichotomous (Yes/No) items. Scores are linearly transformed to a 0-100 scale, where higher scores indicate greater symptom burden.

  7. Treatment Adherence

    Time frame: Completion of radiotherapy (up to approximately 46 days)

    Proportion of participants completing radiotherapy according to protocol, and reasons for non-completion.

  8. Incidence and Severity of Lymphopenia

    Time frame: Up to 24 months

    Will be classified according to CTCAE.

Study contacts

Contact information is provided by the study sponsor or research team.

Isabel Linares

CONTACT

[email protected]

+34667129210

Paula Anglada

CONTACT

[email protected]

+34633685422

Sponsors and collaborators

Lead sponsor

Institut Català d'Oncologia

Other

Registry information

Official study title

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

Acronym: CLEAR

Important dates

Study start
2026
Primary completion
2027
Study completion
2030
First posted
Aug 10, 2026
Registry last updated
Aug 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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