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

Not Applicable

Recruiting

• Conditions: Head and Neck Carcinoma
• Interventions: Radiation: Elective nodal de-escalation arm

• Registration Number: NCT05650034
• Lead Sponsor: National Cancer Institute, Egypt

Brief 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.

Detailed Description

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 positive and tumor was well lateralized, contralateral nodal negativity will be assessed by PETCT. IF PETCT is free, the ipsilateral nodal regions will be irradiated with conventional doses while the contralateral nodal irradiation will be omitted.

* If ipsilateral N positive and tumor was not well lateralized, ipsilateral nodal regions will be irradiated with conventional doses while the contralateral nodal irradiation will be de-escalated to 40 Gy dose equivalent.

* Cases with PETCT positive for malignancy will be excluded from the study.

Bilateral nodal dissection:

* If bilateral N0, bilateral nodal irradiation will be omitted.

* If one sided N positive, laterality of the tumor will be assessed:

* In well lateralized tumors, the positive side nodal regions will be irradiated while the contralateral nodal irradiation will be omitted.

* In midline/ non lateralized tumor the positive side nodal regions will be irradiated with conventional doses while the contralateral nodal irradiation will be de-escalated to 40 Gy dose equivalent.

* If bilateral N positive, cases will be excluded from the study.

Study Timeline

• Study Start: 2021-04-15
• Status Verified: 2022-09
• Study First Submitted: 2022-12-06
• Study First Submitted QC: 2022-12-06
• Last Update Submitted: 2022-12-06
• Study First Posted: 2022-12-14
• Last Update Posted: 2022-12-14
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 57

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Elective nodal de-escalation arm	Elective nodal de-escalation arm	Omission of elective nodal irradiation in N0 hemi-neck of well lateralized H\&N SCCs ( pN0 or by PETCT). Dose de-escalation of elective nodal irradiation in N0 hemi-neck of midline H\&N SCCs ( pN0 or by PETCT).

Primary Outcome Measures

Name	Time	Method
Regional failure in the omitted/de-escalated elective nodal irradiation site	Baseline to 1 year

Secondary Outcome Measures

Name	Time	Method
Late toxicity	Baseline to 1 year
Acute toxicity	Baseline to 6 months
Overall survival	Baseline to 2 years

Trial Locations

Locations (1)

National Cancer Institute; 🇪🇬 Cairo, Egypt