NCT02703493

Image-Guided Stereotactic Radiosurgery (SRS) Boost for HPV-Oropharyngeal Cancer

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Northwell Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer of the Oropharynx

Interventions

Type	Name	Description
RADIATION	Stereotactic Radiosurgery	Patients will receive 6 weeks of IMRT (standard of care) followed by the stereotactic radiosurgery (SRS Boost). Dose of the boost is reliant on which cohort the patient is assigned to. Cohort 1 will receive 8 Gy, Cohort 2 will receive 10 Gy in a single fraction, Cohort 3 will receive 10 Gy split into two fractions.

Timeline

• Start date: 2010-03-01
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2016-03-09
• Last updated: 2024-03-12

Locations

1 site across 1 country: United States