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Radiation
Stereotactic Radiotherapy for Laryngeal Cancer
Phase 1
Recruiting
Led By Jack Phan, 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
Patients older than 18 years of age with histologically proven squamous cell carcinoma of the larynx
ECOG (Zubrod) performance status 0-2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 years
Awards & highlights
Study Summary
This trial is testing a new radiation treatment for laryngeal cancer to see if it is safe and effective.
Who is the study for?
Adults over 18 with laryngeal cancer (specifically squamous cell carcinoma) at certain stages, who can understand English and consent to the study. They must be fit for a specific surgery, agree to use contraception, and not have had prior head/neck radiation or recent potent immunosuppressive drugs.Check my eligibility
What is being tested?
The trial is testing the highest dose of HYDRA radiation that's safe for laryngeal cancer patients. It involves giving focused high-dose radiation in fewer sessions than traditional therapy and includes completing questionnaires about the experience.See study design
What are the potential side effects?
Potential side effects may include skin redness, sore throat, difficulty swallowing, changes in voice quality due to irritation or damage from the targeted high-dose radiation. The severity will vary among individuals.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am over 18 and have been diagnosed with larynx cancer.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
My cancer is at a specific stage according to AJCC criteria.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum Tolerated Dose (MTD) of Stereotactic Hypofractionated RadioAblative (HYDRA) Treatment
Secondary outcome measures
Overall Complete Response Rate of Stereotactic Hypofractionated RadioAblative (HYDRA) Treatment
Trial Design
1Treatment groups
Experimental Treatment
Group I: Stereotactic Hypofractionated Radioablation (HYDRA)Experimental Treatment2 Interventions
Participants receive HYDRA radiation on up to 5 days over the course of about 2 weeks, and for a total of 5 times.
Questionnaires completed at Baseline, on days receiving HYDRA, 6 weeks after last dose of HYDRA, 3 months after last dose of HYDRA, and 6 months after last dose of HYDRA. Also after the 6 month follow-up visit, every 3 months for the first 2 years, and then every 6 months after that for up to 5 years.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Questionnaires
2013
Completed Phase 2
~3330
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,981 Previous Clinical Trials
1,789,814 Total Patients Enrolled
Cancer Prevention Research Institute of TexasOTHER
50 Previous Clinical Trials
98,427 Total Patients Enrolled
Jack Phan, MD, PHDPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has spread to other parts of my body.I am over 18 and have been diagnosed with larynx cancer.I have received initial chemotherapy for my cancer.I have had cancer before, but it was either skin cancer treated with local therapy or cervical cancer.I have had radiation therapy to my head or neck.I have a tracheostomy for severe airway issues or directly through a tumor.I am considered fit for a specific throat surgery by my doctor.I can take care of myself and am up and about more than half of my waking hours.I agree to use birth control or abstain from sex during and for 90 days after the study.I haven't taken strong immune-weakening drugs in the last 6 months.I have had surgery to remove my primary cancer.My cancer is at a specific stage according to AJCC criteria.You have a serious, ongoing health problem according to certain rules.
Research Study Groups:
This trial has the following groups:- Group 1: Stereotactic Hypofractionated Radioablation (HYDRA)
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.
How effective is Stereotactic Hypofractionated Radioablation in promoting patient health and wellbeing?
"As the trial is currently in its first phase, there is only scant evidence available to support both safety and efficacy of Stereotactic Hypofractionated Radioablation. Thus, it received a score of 1 from our team at Power."
Answered by AI
Are there any vacancies left for people to join this research endeavor?
"According to the clinicaltrials.gov database, this medical experiment is no longer recruiting patients and hasn't been since September 28th 2022 - when it was last updated. However, there are still 3113 other trials that are actively taking on participants at present time."
Answered by AI
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