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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
Study 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.Check my eligibility
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.See study design
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion; an average of 1 year.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
M. D. Anderson Symptom Inventory - Head & Neck (MDASI-HN) Questionnaires
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
2014
Completed Phase 4
~370
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,985 Previous Clinical Trials
1,789,009 Total Patients Enrolled
Jay Reddy, MD,PHDPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer cannot be cured with surgery or radiation, as decided by a team of doctors.I am 18 years old or older.My cancer has spread to other parts of my body.My cancer is confirmed to be squamous cell carcinoma.My cancer originates in the head or neck area.I cannot undergo radiotherapy due to health reasons.I've had cancer treatments like radiation or surgery, but may not be suitable for more radiation.
Research Study Groups:
This trial has the following groups:- Group 1: Stereotactic body radiotherapy (SBRT)
- Group 2: Traditional Palliation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is Traditional Palliation a secure and reliable treatment option for patients?
"Traditional Palliation's safety has been observed in the Phase 2 trial, and thus it was allocated a score of 2. As this phase does not evaluate efficacy, that metric is still unknown."
Answered by AI
Does this research have any open slots for new participants?
"The data on clinicaltrials.gov indicates that this particular trial is no longer open for recruitment, having first been posted on June 30th 2023 and last updated December 21st 2022. However, there are presently 2584 other trials seeking participants across the globe."
Answered by AI
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