Ignite Creation Date:
2024-05-06 @ 4:06 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04870840
Status:
COMPLETED
Last Update Posted:
2023-07-27
First Post:
2020-06-23
Brief Title:
Image-guided Proton Therapy for the Treatment of Locally Advanced Unresectable Head and Neck Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Proton Image-Guided Radiation Assignment for Therapeutic Escalation Via Selection of Locally Advanced Head and Neck Cancer Patients PIRATES
Status:
COMPLETED
Status Verified Date:
2023-07
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 phase I trial studies the side effects of image-guided hyper-fractioned proton therapy in treating patients with head and neck cancer that has spread to nearby tissue or lymph nodes locally advanced and cannot be removed by surgery unresectable Radiation therapy uses high energy protons to kill tumor cells and shrink tumors The change in dose radiation frequency and dose investigated in this study may help to better control the tumor and prevent it from coming back or growing The goal of this study is to test a new radiation schedule that administers more radiation to the tumor tissue using image guided proton therapy for patients that have a high risk of having a tumor recurrence the tumor comes back after treatment
Detailed Description:
PRIMARY OBJECTIVE
I To assess the safety feasibility of image guided mid-treatment hyper-fractioned dose-escalation with proton therapy and identify the maximum tolerable dose MTD for the treatment of locally advanced human papillomavirus HPV negative head and neck cancer
OUTLINE
Patients undergo radiation therapy once daily QD 5 days a week Monday through Friday for the first 18 days and then twice daily BID for 15 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up at 8 weeks 3 6 9 and 12 months in the first year after radiation therapy every 4 months in the second year after radiation therapy and then every 9 months thereafter
I To assess the safety feasibility of image guided mid-treatment hyper-fractioned dose-escalation with proton therapy and identify the maximum tolerable dose MTD for the treatment of locally advanced human papillomavirus HPV negative head and neck cancer
OUTLINE
Patients undergo radiation therapy once daily QD 5 days a week Monday through Friday for the first 18 days and then twice daily BID for 15 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up at 8 weeks 3 6 9 and 12 months in the first year after radiation therapy every 4 months in the second year after radiation therapy and then every 9 months thereafter
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2020-04072 | REGISTRY | None | None |
| 2019-0467 | OTHER | M D Anderson Cancer Center | None |