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

Head and Neck Carcinoma Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05650034
Study type Interventional
Source National Cancer Institute, Egypt
Contact Sara A Elsharkawy
Phone +20 2 2368 4423
Email Sara.elsharkawy@nci.cu.edu.eg
Status Recruiting
Phase N/A
Start date April 15, 2021
Completion date December 2023
View Details
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