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Radiation Therapy

Stereotactic Radiosurgery for Oropharyngeal Cancer

N/A
Waitlist Available
Led By Maged Ghaly, MD
Research Sponsored by Northwell Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to two years post srs boost
Awards & highlights

Study Summary

This trial is testing if a higher dose of radiation can be safely used to treat a certain type of throat cancer.

Eligible Conditions
  • Oropharyngeal Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to two years post srs boost
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to two years post srs boost for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety and dose-limiting toxicity of dose escalated stereotactic radiotherapy in patients with high-risk oropharyngeal squamous cancer using (CTCAE), version 4.03
Secondary outcome measures
Disease response using Revised RECIST guideline (version 1.1)

Side effects data

From 2019 Phase 2 trial • 32 Patients • NCT01573702
32%
Fatigue
28%
Lymphocyte count decreased
24%
Cough
20%
Back pain
20%
Rash acneiform
16%
Anorexia
16%
Dry skin
16%
Hyperglycemia
16%
Rash maculo-papular
12%
Aspartate aminotransferase increased
12%
Non-cardiac chest pain
12%
Diarrhea
12%
Dyspepsia
12%
Headache
12%
Nausea
12%
Pain
12%
Pain in extremity
8%
Weight loss
8%
Wheezing
8%
Urinary tract pain
8%
Watering eyes
8%
Arthralgia
8%
Edema limbs
8%
Abdominal pain
8%
Myalgia
8%
Paronychia
8%
Pruritus
8%
Blurred vision
8%
Skin and subcutaneous tissue disorders - Other, specify
4%
Skin infection
4%
Urinary tract infection
4%
White blood cell decreased
4%
Vomiting
4%
Sore throat
4%
Upper respiratory infection
4%
Urinary urgency
4%
Ear pain
4%
Oral hemorrhage
4%
Conjunctivitis
4%
Alkaline phosphatase increased
4%
Blood bilirubin increased
4%
Bone pain
4%
Bruising
4%
Depression
4%
Dry eye
4%
Dysgeusia
4%
Dysphagia
4%
Edema face
4%
Epistaxis
4%
Flashing lights
4%
Flu like symptoms
4%
Gastroesophageal reflux disease
4%
Hot flashes
4%
Hyperkalemia
4%
Hypernatremia
4%
Infusion site extravasation
4%
Insomnia
4%
Lethargy
4%
Nail loss
4%
Nail ridging
4%
Neck pain
4%
Neutrophil count decreased
4%
Papulopustular rash
4%
Platelet count decreased
4%
Pneumonitis
4%
Fracture
4%
Fall
4%
Skin hyperpigmentation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Stereotactic Radiosurgery Followed by Erlotinib

Trial Design

1Treatment groups
Experimental Treatment
Group I: Cohort 1Experimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Radiosurgery
2016
Completed Phase 2
~460

Find a Location

Who is running the clinical trial?

Northwell HealthLead Sponsor
458 Previous Clinical Trials
470,894 Total Patients Enrolled
Maged Ghaly, MDPrincipal InvestigatorNorthwell Health- Center for Advanced Medicine
1 Previous Clinical Trials
22 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this medical research program have open enrollment?

"The clinicaltrials.gov website shows that this trial, which was initially listed on March 1st 2010 and last updated February 3rd 2022 has finished patient recruitment. Nevertheless, at the moment 94 other trials are recruiting participants."

Answered by AI
~3 spots leftby Mar 2025