Ignite Creation Date:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2025-12-25 @ 11:20 PM
Study NCT ID:
NCT02703493
Status:
COMPLETED
Last Update Posted:
2024-03-12
First Post:
2015-12-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Image-Guided Stereotactic Radiosurgery (SRS) Boost for HPV-Oropharyngeal Cancer
Sponsor:
Northwell Health
Organization:
Study Overview
Official Title:
A Phase I Trial of IMRT With Dose-Escalated Image-Guided Stereotactic Radiosurgery (SRS) Boost for Human Papilloma Virus (HPV)- Unassociated Oropharyngeal Cancer
Status:
COMPLETED
Status Verified Date:
2024-03
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 Phase I study looking to evaluate the safety of dose escalated stereotactic radiotherapy (SRS) without exceeding the maximum tolerated dose in patients with high-risk human papilloma virus (HPV)- unassociated oropharyngeal squamous cancer.
Detailed Description:
Human Papilloma Virus (HPV) is frequently found within tumor cells removed from patients diagnosed with oropharynx cancer. Tumors which do not contain HPV virus (termed "HPV-Negative") are not cured as frequently by radiation therapy. Tumors which do contain HPV in patients who have a history of cigarette smoking also are not cured as frequently by radiation.
One way to potentially overcome this challenge is to deliver a more intense dose of radiation treatment to the tumor. The standard way to deliver radiation, termed Intensity Modulated Radiotherapy (IMRT), can protect normal tissues near tumors to a certain degree but not completely. Stereotactic radiosurgery (SRS) is a technique which can deliver radiation more precisely.
This trial will test the safety of treating HPV-unassociated oropharynx tumors to higher radiation doses wth SRS (termed a "boost") after a standard course of IMRT has been given. In addition, the investigators will look at whether magnetic resonance imaging (MRI) scanning can detect treatment response in oropharynx tumors earlier than with standard tests.
One way to potentially overcome this challenge is to deliver a more intense dose of radiation treatment to the tumor. The standard way to deliver radiation, termed Intensity Modulated Radiotherapy (IMRT), can protect normal tissues near tumors to a certain degree but not completely. Stereotactic radiosurgery (SRS) is a technique which can deliver radiation more precisely.
This trial will test the safety of treating HPV-unassociated oropharynx tumors to higher radiation doses wth SRS (termed a "boost") after a standard course of IMRT has been given. In addition, the investigators will look at whether magnetic resonance imaging (MRI) scanning can detect treatment response in oropharynx tumors earlier than with standard tests.
Study Oversight
Has Oversight DMC:
True
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?: