Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-25 @ 2:21 AM
NCT ID:
NCT05650034
Eligibility Criteria:
Inclusion Criteria:
* Patients with a Karnofsky performance score of 70% or more.
* Completely or partially resected head and neck SCC. This includes: The oral cavity (lips, buccal mucosa, oral tongue, floor of mouth, gingiva, retromolar trigone, and hard palate), maxilla, oropharynx, and larynx.
* Patients with at least an ipsilateral neck dissection.
* Patient has at least one pathological feature that is an indication for PORT: positive or close (\<5 mm) margin, presence of LVI or PNI, pT3 or pT4 disease, positive lymph nodes, or ENE.
* Pathologically lymph node negative in at least one dissected hemi-neck or PET-CT
Exclusion Criteria:
* Patients with bilaterally involved neck nodes
* Patients with pT3-T4 tumors involving midline who undergo an ipsilateral neck dissection (unless a contralateral neck dissection is performed)
* Serious medical comorbidities or other contraindications to radiotherapy
* Prior history of head and neck cancer within 5 years
* Any other active invasive malignancy
* Prior head and neck radiation at any time
* Prior oncologic head and neck surgery in the oral cavity or neck.
* Known metastatic disease
* Locoregional disease recurrence identified following surgical resection but prior to start of radiotherapy
* Inability to attend full course of radiotherapy or follow-up visits 11.Unable or unwilling to complete QoL questionnaires
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
78 Years
Study:
NCT05650034
Study Brief:
Protocol Section:
NCT05650034