← Back to Search

Radiation Therapy

Stereotactic Body Radiation Therapy for Head and Neck Cancer

N/A

Waitlist Available

Led By Robert Chin, MD

Research Sponsored by Jonsson Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically confirmed recurrent head and neck cancer; either unresectable or status post salvage surgery.

Maximum tumor, or tumor bed, diameter < 5 cm.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial is testing a new radiation therapy method to treat head and neck cancer that has returned. The new method uses special equipment to position the patient and deliver radiation to tumors with high precision.

Who is the study for?

This trial is for adults with recurrent head and neck cancer that's less than 5 cm wide. Participants must be relatively fit (Karnofsky score >=70), not pregnant, agree to use birth control, have a life expectancy over 12 weeks, and have had prior radiation therapy with significant overlap to the current treatment area.Check my eligibility

What is being tested?

The study tests how well HyperArc technology delivers stereotactic body radiation therapy to target tumors in the head and neck more precisely. The goal is fewer doses, shorter treatment time, and minimal damage to healthy tissue.See study design

What are the potential side effects?

Potential side effects include skin reactions at the treatment site, fatigue, dry mouth or throat due to radiation exposure, difficulty swallowing, changes in taste sensation, and possible late-term effects like fibrosis or secondary cancers.

Eligibility Criteria

Inclusion Criteria

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

Select...

My head or neck cancer has come back and cannot be removed or has been operated on.

Select...

My tumor or the area where my tumor was is smaller than 5 cm.

Select...

I am mostly able to care for myself and carry out daily activities.

Select...

I've had radiation for head/neck cancer with significant overlap in treatment areas.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Local control rate of the treated tumor target per Response Evaluation Criteria in Solid Tumors version 1.1, magnetic resonance imaging (MRI) response or positron emission tomography (PET) response

Percent of patients with acute or chronic grade >= 3 treatment-related toxicity per Common Terminology Criteria for Adverse Events version 4.0

Secondary outcome measures

LPFS

Locoregional progression-free survival (LPFS)

Median LPFS

+6 more

Other outcome measures

Dosimetric data including achievable dose to target and organs at risk (OAR)

Serum markers predictive of response and/or toxicity

Side effects data

From 2022 Phase 2 trial • 29 Patients • NCT02045446

79%

Cough

64%

Nausea

64%

Dyspnea

57%

Fatigue

43%

Constipation

36%

Pain

36%

Dizziness

29%

Back pain

29%

Anemia

29%

Vomiting

21%

Anorexia

21%

Lymphocyte count decreased

21%

Chest pain

21%

Death NOS

21%

Anxiety

21%

Fall

14%

Wheezing

14%

Dysphagia

14%

Depression

14%

Hypotension

14%

Diarrhea

14%

Platelet count decreased

14%

Abdominal Pain

14%

Edema

14%

Fever

14%

Headache

14%

Insomnia

14%

Palpitations

Creatinine increased

Alopecia

Confusion

Sinusitis

Dysgeusia

Hemorrhoids

Dementia

Productive cough

Dysuria

Throat pain

Hearing impaired

Rash

Bone marrow biopsy

Hypernatremia

Eye pain

Tachycardia

Lung infection

Amnesia

Neuropathy

Dehydration

Pneumonitis

Pleuritic pain

Otitis externa

White blood cell count decreased

Neutropenia

Hypertension

Blurred vision

Hypoxia

Aspiration pneumonia

Blood bilirubin increased

Muscle weakness

Tremor

Weight loss

Thrombocytopenia

Floaters

Toothache

Esophagitis

Leukocytosis

Edema limbs

Gait disturbance

Parathesia (tingling)

Edema face

COPD

100%

80%

60%

40%

20%

Study treatment Arm

Stereotactic Body Radiation Therapy

Maintenance Chemotherapy

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (SBRT)Experimental Treatment3 Interventions

Patients undergo stereotactic body radiation therapy with either standard radiation treatment software or HyperArc software technology for 2-3 fractions per week over a 2-week period for 5 fractions.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Stereotactic Body Radiation Therapy

2012

Completed Phase 2

~780

0 / 4Eligibility criteria met