Ignite Creation Date:
2024-05-06 @ 6:51 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05800574
Status:
RECRUITING
Last Update Posted:
2024-04-09
First Post:
2023-03-24
Brief Title:
Lymphoscintigraphy Directed Elective Neck Radiation for p16 Favorable Risk Oropharynx Cancer
Sponsor:
Fox Chase Cancer Center
Organization:
Fox Chase Cancer Center
Study Overview
Official Title:
A Phase II Investigation of Lymphoscintigraphy Directed Elective Neck Radiation for p16 Favorable Risk Oropharynx Cancer Patients Managed With Primary Chemo Radiation
Status:
RECRUITING
Status Verified Date:
2024-04
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 prospective phase II stratified single arm investigation for favorable prognosis in p16 oropharynx cancer patients with either node negative or malignant neck adenopathy with lymphoscintigraphy mapping confined to the ipsilateral neck
Detailed Description:
This is a prospective phase II stratified single arm investigation for favorable prognosis in p16 oropharynx cancer patients with either node negative or malignant neck adenopathy with lymphoscintigraphy mapping confined to the ipsilateral neck Patients positive for p16 status will be approached for consent during the pre-treatment intake process Contralateral neck progression will be measured by PET positron emission tomographyCT scans Xerostomia will be measured by the EORTC QLQ European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire HN35 at 6 12 and 24 months Patients will remain on study treatment for 6-7 weeks or until unacceptable toxicity or withdrawal of consent Disease free survival DFS and overall survival OS will be assessed until 24 months after completion of study treatment
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HN-107 | OTHER | Fox Chase Cancer Center | None |