Omitting Postoperative Cervical Radiation in Select Head and Neck Cancer Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 trial evaluates a selective approach to postoperative radiotherapy by excluding cervical radiation when patients have undergone systematic neck dissection and show no high-risk nodal features. Participants receive IMRT or VMAT that omits the cervical nodal irradiation, with outcomes compared to published data and retrospective controls treated with standard complete nodal irradiation. Primary questions include whether regional recurrence is non-inferior to standard rates, and whether this approach lowers toxicity and preserves immune function and quality of life. Eligibility targets adults with locally advanced squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx who have specific nodal pathology and meet criteria suggesting benefit from reduced radiation. The trial is sponsored by Institut Català d'Oncologia and is conducted at their L’Hospitalet de Llobregat site in Barcelona.

Why it matters

Who can join: the full rules

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

Where it's running

• Institut Català d'Oncologia
  L'Hospitalet de Llobregat, Barcelona, Spain Recruiting

Study contacts

• Study coordinator: Isabel Linares
• Email: ilinaresgaliana@iconcologia.net
• Phone: +34667129210

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.