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Radiation Therapy

Stereotactic Body Radiation Therapy for Head and Neck Cancer

Phase 2
Recruiting
Led By Jay Reddy, MD,PHD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year.
Awards & highlights
No Placebo-Only Group

Summary

This trial investigates if advanced radiation techniques can safely deliver a strong dose of radiation to tumors more quickly than usual.

Who is the study for?
This trial is for adults with squamous cell carcinoma in the head and neck region, who can't have curative treatment. They may have had previous treatments but are not eligible for further radiation as per their doctor's assessment. Pregnant or breastfeeding women cannot participate, and participants must consent to detailed examinations and provide a smoking history.
What is being tested?
The study is testing whether stereotactic body radiotherapy (SBRT) can deliver high doses of radiation effectively over a shorter period compared to traditional palliative methods. Participants will be randomly assigned to receive either SBRT or conventional palliation.
What are the potential side effects?
Potential side effects from SBRT could include skin reactions, fatigue, dry mouth, difficulty swallowing, changes in taste sensation, nausea, and inflammation of surrounding tissues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year.
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
M. D. Anderson Symptom Inventory - Head & Neck (MDASI-HN) Questionnaires

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Traditional PalliationExperimental Treatment1 Intervention
Participant will be randomized to standard radiation
Group II: Stereotactic body radiotherapy (SBRT)Experimental Treatment1 Intervention
Participants will be randomized to receive (SBRT) Stereotactic body radiotherapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic body radiotherapy
2021
Completed Phase 4
~840

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,068 Previous Clinical Trials
1,802,521 Total Patients Enrolled
Jay Reddy, MD,PHDPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Stereotactic Body Radiotherapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05674396 — Phase 2
Head and Neck Squamous Cell Carcinoma Research Study Groups: Stereotactic body radiotherapy (SBRT), Traditional Palliation
Head and Neck Squamous Cell Carcinoma Clinical Trial 2023: Stereotactic Body Radiotherapy Highlights & Side Effects. Trial Name: NCT05674396 — Phase 2
Stereotactic Body Radiotherapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05674396 — Phase 2
~40 spots leftby Sep 2025