Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06445114
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-05-22
Brief Title:
Using CircuLating Tumor DNA to Risk Adapt Post-Operative Therapy for HPV-associated Oropharyngeal Cancer
Sponsor:
Zachary Zumsteg
Organization:
Cedars-Sinai Medical Center
Study Overview
Official Title:
ULTRA-HPV Using Circulating Tumor DNA to Risk Adapt Post-operative Therapy for HPV Associated Oropharyngeal Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a single institution phase II study that will enroll patients with T0-3N0-2 p16-positive oropharyngeal squamous cell carcinoma OSCC undergoing resection of all gross visible disease at the primary site and in the lymph nodes
Detailed Description:
All eligible patients will be treated with a de-intensified cisplatin-based chemoradiation regimen after undergoing transoral robotic surgery Enrolled patients will be risk-assessed and assigned to specific regimens based on a combination of their post-operative cTTMV-HPV DNA as determined by results from NavDx kits by Naveris and pathologic features All patients will receive a dose of 40 mgm2 IV weekly concurrently with radiation therapy Patients ineligible to receive cisplatin at this dose will undergo modified sydtemic therapy Patients will recieve concurrent radiation in a dose of 30 Gy in 15 fractions to the primary tumor bed ipsilateral neck - contralateral neck Based on risk-stratification some patients will receive a sequential boost of 10 Gy over 5 fractions or 20 Gy over 10 fractions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None