Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06607406
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-18
Brief Title:
Postoperative Radiotherapy for Intermediate- and High-risk Patients With HNSCC Greater Than 6 Weeks After Surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Trial of Accelerated Postoperative Radiotherapy for Intermediate- and High-risk Patients With HNSCC Head and Neck Squamous Cell Carcinoma Initiating Radiotherapy Greater Than 6 Weeks After Surgery PORTRush
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to determine whether accelerated radiotherapy involving 6 treatments per week is better than standard radiotherapy involving 5 treatments per week at treating cancer of the head and neck when initiated more than 6 weeks after surgery
Detailed Description:
This study is a randomized trial designed to determine the effect of Accelerated Fractionation AF versus Conventional Fractionation CF PORT on locoregional recurrence-free survival progression-free survival overall survival toxicity and treatment package time in participants with resected intermediate and high-risk Head and Neck Squamous Cell Carcinoma HNSCC planned to start Post Operative Radiotherapy PORT greater than six weeks after surgery Eligible participants in both cohorts will be randomized 11 to receive five fractions per week of standard conventional fractionation radiotherapy or six fractions per week of accelerated fractionation radiotherapy If randomized to the standard conventional fractionation group participants will be treated with five fractions of radiation per week received daily If randomized to the accelerated fractionation group participants will be treated with 6 fractions of radiotherapy per week received daily and twice daily treatments on one day of the week
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None