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Recruiting NCT05650034

Post-Operative Radiotherapy De-Escalation of Negative Nodal Regions in Head and Neck Squamous Cell Carcinoma

Conditions: Head and Neck Carcinoma

Sex: All
Ages: 18 Years – 78 Years
Phase: NA
Enrollment: 57
Sponsor: National Cancer Institute, Egypt

Location: Egypt

Summary

This is a non-randomized prospective trial evaluating the non- inferiority of de-escalating the volume and/or dose of elective nodal irradiation in post-operative head and neck squamous cell carcinomas.

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-CTExclusion Criteria:Patients with bilaterally involved neck nodesPatients 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 radiotherapyPrior history of head and neck cancer within 5 yearsAny other active invasive malignancyPrior head and neck radiation at any timePrior oncologic head and neck surgery in the oral cavity or neck.Known metastatic diseaseLocoregional disease recurrence identified following surgical resection but prior to start of radiotherapyInability to attend full course of radiotherapy or follow-up visits 11.Unable or unwilling to complete QoL questionnaires

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05650034). StuddyBuddy aggregates publicly available trial information.