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

Launched by NATIONAL CANCER INSTITUTE, EGYPT · Dec 6, 2022

Keywords

ClinConnect Summary

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

57 head and neck squamous cell carcinoma cases eligible for post-operative radiotherapy will be recruited and managed according to tumor laterality, nodal status, and laterality of nodal dissection (ipsilateral/ bilateral nodal dissection).

Ipsilateral nodal dissection:

* If ipsilateral N0, bilateral nodal irradiation will be omitted.
* If ipsilateral N pos...

Gender

ALL

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

Trial Officials