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Radiation Therapy

Stereotactic Body Radiation Therapy for Head and Neck Cancer

N/A

Recruiting

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

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

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

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

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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%

Dyspnea

64%

Nausea

57%

Fatigue

43%

Constipation

36%

Pain

36%

Dizziness

29%

Anemia

29%

Back pain

29%

Vomiting

21%

Chest pain

21%

Anorexia

21%

Lymphocyte count decreased

21%

Death NOS

21%

Anxiety

21%

Fall

14%

Wheezing

14%

Dysphagia

14%

Hypotension

14%

Depression

14%

Diarrhea

14%

Platelet count decreased

14%

Abdominal Pain

14%

Edema

14%

Fever

14%

Headache

14%

Insomnia

14%

Palpitations

Alopecia

Dehydration

Creatinine increased

Otitis externa

Sinusitis

Dysgeusia

Hemorrhoids

Amnesia

Confusion

Dementia

Productive cough

Pneumonitis

Dysuria

White blood cell count decreased

Throat pain

Bone marrow biopsy

Hearing impaired

Rash

Hypernatremia

Eye pain

Blurred vision

Tachycardia

Lung infection

Neuropathy

Hypertension

Pleuritic pain

Neutropenia

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

Find a Location

Who is running the clinical trial?

Jonsson Comprehensive Cancer CenterLead Sponsor

360 Previous Clinical Trials

27,659 Total Patients Enrolled

Varian, a Siemens Healthineers CompanyIndustry Sponsor

30 Previous Clinical Trials

7,220 Total Patients Enrolled

Robert Chin, MDPrincipal InvestigatorUCLA / Jonsson Comprehensive Cancer Center

Media Library

HyperArc (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03892720 — N/A

Head and Neck Cancers Research Study Groups: Treatment (SBRT)

Head and Neck Cancers Clinical Trial 2023: HyperArc Highlights & Side Effects. Trial Name: NCT03892720 — N/A

HyperArc (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03892720 — N/A

Frequently Asked Questions

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

How many individuals have been recruited to participate in this research endeavor?

"Affirmative. Clinicaltrials.gov confirms that this research trial, which was initially posted on March 27th 2019 is currently recruiting patients for participation. The study needs 53 volunteers from a single medical facility."

Answered by AI

Are individuals able to join this research endeavor currently?

"Affirmative, the details uploaded to clinicaltrials.gov demonstrate that this research endeavor is presently recruiting participants who first signed up on March 27th 2019 and was recently edited on March 30th 2022. 53 volunteers are needed at a single medical site."

Answered by AI

What are the fundamental purposes of this experiment?

"According to the study sponsor, Varian - a Siemens Healthineers Company - the primary endpoint evaluated over a one-year period is the percentage of patients who suffer from adverse events of grade 3 and higher. Secondary objectives include Progression-free Survival (PFS), Locoregional Progression Free Survival (LPFS) as well as Median LPFS which will all be estimated using Kaplan Meier methods with 95% confidence intervals."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Stereotactic Body Radiation Therapy Using HyperArc in Treating Patients With Recurrent Head and Neck Cancer

2019. "Stereotactic Body Radiation Therapy Using HyperArc in Treating Patients With Recurrent Head and Neck Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03892720.