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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.
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:
Bilateral nodal dissection:
If bilateral N0, bilateral nodal irradiation will be omitted.
If one sided N positive, laterality of the tumor will be assessed:
If bilateral N positive, cases will be excluded from the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elective nodal de-escalation arm | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elective nodal de-escalation arm | Radiation | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Regional failure in the omitted/de-escalated elective nodal irradiation site | Baseline to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Acute toxicity | Baseline to 6 months | |
| Late toxicity | Baseline to 1 year | |
| Overall survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sara A Elsharkawy | Contact | +20 2 2368 4423 | Sara.elsharkawy@nci.cu.edu.eg | |
| May Ashour | Contact | May25s@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Tarek Shouman | National Cancer Institute, Egypt | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Institute | Recruiting | Cairo | 11796 | Egypt |
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| Baseline to 2 years |