Ignite Creation Date:
2024-05-06 @ 7:18 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05962242
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-13
First Post:
2023-06-30
Brief Title:
HPV DNA-Guided Radiotherapy De-intensification of Head and Neck Squamous Cell Carcinoma
Sponsor:
University of Virginia
Organization:
University of Virginia
Study Overview
Official Title:
Circulating Tumor Modified HPV DNA-Guided Radiotherapy De-intensification of the Elective Neck RaDEN in Squamous Cell Carcinoma of the Head and Neck
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
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:
HN001
Brief Summary:
The study will evaluate the safety and effectiveness of a lower than standard dose of radiation for definitive or adjuvant treatment of head and neck squamous cell carcinomas
Detailed Description:
In squamous cell carcinomas of the head and neck regional recurrence is rare within lymph node stations treated with elective radiation However radiotherapy to the neck is toxic and leads to a variety of unpleasant side effects especially coupled with concurrent systemic therapy There is growing evidence from previous studies showing that lower radiation doses may be adequate in preventing locoregional recurrence of disease The hypothesis is that lower dose of radiation will have equal effectiveness but less toxicity than standard approaches for the treatment of squamous cell carcinomas of the head and neck
The study evaluates the effectiveness and safety of reduced dose radiotherapy for definitive and adjuvant treatment of Human papillomavirus HPV positive oropharyngeal squamous cell carcinomas
Participants will be treated with a radiation therapy regimen that has a lower dose to less tissue area dose and volume de-escalation than standard of care radiation therapy The dosing will be determined by whether concurrent chemotherapy will be given results from on treatment HPV blood test called NavDx physical exam and imaging On treatment NavDx results indicating a slow non-rapid response to the treatment will receive an additional boost of radiation Routine NavDx testing will be performed to assess treatment response and recurrence Participants will also be asked to complete surveys about overall health and wellbeing
The study evaluates the effectiveness and safety of reduced dose radiotherapy for definitive and adjuvant treatment of Human papillomavirus HPV positive oropharyngeal squamous cell carcinomas
Participants will be treated with a radiation therapy regimen that has a lower dose to less tissue area dose and volume de-escalation than standard of care radiation therapy The dosing will be determined by whether concurrent chemotherapy will be given results from on treatment HPV blood test called NavDx physical exam and imaging On treatment NavDx results indicating a slow non-rapid response to the treatment will receive an additional boost of radiation Routine NavDx testing will be performed to assess treatment response and recurrence Participants will also be asked to complete surveys about overall health and wellbeing
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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