Image-Guided Stereotactic Radiosurgery (SRS) Boost for HPV-Oropharyngeal Cancer
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|ClinicalTrials.gov Identifier: NCT02703493|
Recruitment Status : Completed
First Posted : March 9, 2016
Last Update Posted : August 31, 2021
|Condition or disease||Intervention/treatment||Phase|
|Cancer of the Oropharynx||Radiation: Stereotactic Radiosurgery||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||39 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Dose escalation of radiation therapy for high risk oropharyngeal cancer|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||March 1, 2010|
|Actual Primary Completion Date :||May 1, 2020|
|Actual Study Completion Date :||May 1, 2020|
Experimental: Cohort 1
Patients will receive 6 weeks of Intensity-Modulated Radiation Therapy (IMRT) (standard of care) followed by the dose escalated stereotactic radiosurgery (SRS Boost). Cohort 1 will receive 8 Gy in a single fraction, cohort 2 will receive 10 Gy in a single fraction and cohort 3 will receive 10 Gy split into two fractions.
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.
Other Name: SRS
- Safety and dose-limiting toxicity of dose escalated stereotactic radiotherapy in patients with high-risk oropharyngeal squamous cancer using (CTCAE), version 4.03 [ Time Frame: up to five years post SRS Boost ]
- Disease response using Revised RECIST guideline (version 1.1) [ Time Frame: up to five years post SRS Boost ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02703493
|United States, New York|
|Northwell Health- Center for Advanced Medicine|
|Lake Success, New York, United States, 11042|
|Principal Investigator:||Maged Ghaly, MD||Northwell Health- Center for Advanced Medicine|