NCT05650034

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 57 (estimated)
• Sponsor: National Cancer Institute, Egypt · Academic / Other
• Sex: All
• Age: 18 Years – 78 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Head and Neck Carcinoma

Interventions

Type	Name	Description
RADIATION	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).

Timeline

• Start date: 2021-04-15
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2022-12-14
• Last updated: 2022-12-14

Locations

1 site across 1 country: Egypt