Image-Guided Stereotactic Radiosurgery (SRS) Boost for HPV-Oropharyngeal Cancer
March 7, 2024 updated by: Maged Ghaly, Northwell Health
A Phase I Trial of IMRT With Dose-Escalated Image-Guided Stereotactic Radiosurgery (SRS) Boost for Human Papilloma Virus (HPV)- Unassociated Oropharyngeal Cancer
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
39
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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Lake Success, New York, United States, 11042
- Northwell Health- Center for Advanced Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients older than 18 years of age with histologically proven squamous cell carcinoma of the oropharynx
- HPV-negative disease status by routine p16 immunohistochemical (IHC) staining or in situ hybridization (ISH) of biopsied tumor tissue or >10 pack-year cigarette smoking history
- Stage T1-4, N0-3 disease, as defined by American Joint Committee on Cancer (AJCC) criteria
- Eastern Cooperative Oncology Group (ECOG) (Zubrod) Performance Status 0-2.
Exclusion Criteria:
- Patients who have undergone resection of primary disease
- Patients who have received induction chemotherapy for their oropharynx cancer diagnosis
- Prior cancer diagnosis within 5 years, except appropriately treated localized epithelial skin cancer or cervical cancer
- Prior radiation therapy to the head and neck region
- Women of childbearing potential (a woman of child-bearing potential is a sexually mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months [i.e., who has had menses at any time in the preceding 24 months]) and male participants must practice effective contraception (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) throughout the study
- Patient unable to tolerate MRI or having an estimated Glomerular Filtration Rate (GFR) <60 ml/min/1.73 m2.
- Severe, active co-morbidity, defined as follows:
- Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
- Transmural myocardial infarction within the last 6 months
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
- Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration
- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol
- Acquired Immune Deficiency Syndrome (AIDS) based upon current Centers for Disease Control (CDC) definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immuno-compromised patients
- History or treatment with potent immunosuppressive drugs for such conditions as organ transplant, severe rheumatoid arthritis, etc. within the past 6 months.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 two years post SRS Boost
|
study completed.
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up to two years post SRS Boost
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Disease response using Revised RECIST guideline (version 1.1)
Time Frame: up to two years post SRS Boost
|
study completed
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up to two years post SRS Boost
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Maged Ghaly, MD, Northwell Health- Center for Advanced Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2010
Primary Completion (Actual)
December 31, 2022
Study Completion (Actual)
December 31, 2022
Study Registration Dates
First Submitted
December 15, 2015
First Submitted That Met QC Criteria
March 8, 2016
First Posted (Estimated)
March 9, 2016
Study Record Updates
Last Update Posted (Actual)
March 12, 2024
Last Update Submitted That Met QC Criteria
March 7, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09-309A
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.