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Radiation Therapy
Hypofractionated Radiation Therapy for Head and Neck Cancer
N/A
Recruiting
Led By Joseph Zenga, MD
Research Sponsored by Medical College of Wisconsin
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 up to one year
Awards & highlights
Study Summary
This trial is testing how safe it is to give patients with head and neck squamous cell carcinoma a condensed course of preoperative radiation.
Who is the study for?
Adults with specific types of head and neck cancer (HPV-negative squamous cell carcinoma) that can be surgically removed. They must have a certain level of overall health, not have had prior invasive cancers in the last three years, no previous treatment for their current cancer, and agree to use contraception if they can have children.Check my eligibility
What is being tested?
The trial is testing different doses of preoperative radiation therapy (46 Gy, 40 Gy, or 35 Gy given in fewer treatments) to see which is safest for treating head and neck squamous cell carcinoma before surgery.See study design
What are the potential side effects?
Radiation therapy may cause side effects like skin irritation at the treatment site, fatigue, dry mouth or throat issues due to inflammation, difficulty swallowing, changes in taste sensation and potential risk of developing other cancers long-term.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The number of subjects with a dose-limiting toxicity related to inoperability.
The number of subjects with a dose-limiting toxicity related to perioperative complication rates.
The number of subjects with severe delayed toxicity.
Secondary outcome measures
Overall survival
Recurrence-free Survival
Trial Design
3Treatment groups
Experimental Treatment
Group I: 46 Gray (Gy)Experimental Treatment1 Intervention
46 gy of radiation therapy will be administered in 10 fractions.
Group II: 40 Gray (Gy)Experimental Treatment1 Intervention
40 gy of radiation therapy will be administered in 7 fractions.
Group III: 35 Gray (Gy)Experimental Treatment1 Intervention
35 gy of radiation therapy will be administered in 5 fractions.
Find a Location
Who is running the clinical trial?
Medical College of WisconsinLead Sponsor
610 Previous Clinical Trials
1,162,695 Total Patients Enrolled
Joseph Zenga, MDPrincipal InvestigatorMedical College of Wisconsin
1 Previous Clinical Trials
25 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 or older with a type of head or neck cancer that is not linked to HPV and can be removed by surgery.I have not been hospitalized for heart issues in the last 3 months.I have not had any other cancer besides skin cancer in the last 3 years.My cancer is HPV-positive squamous cell carcinoma.My throat cancer can be treated without removing my voice box.I had a major heart attack in the last 3 months.My cancer has spread beyond the lymph nodes.I need help with my daily activities due to my health condition.I have received treatment for my cancer before.I have had radiation therapy to my head or neck area.I am not pregnant, and if capable of childbearing or a sexually active man, I am willing to use contraception.My body weight is 30 kg or less.I can take care of myself and am up more than 50% of my waking hours.My cancer is advanced but hasn't spread far from where it started.My cancer is at a stage where it has grown but not spread to lymph nodes.I am mentally and physically able to follow the study's requirements.I agree to use contraception as required.I meet the menopause or birth control requirements.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there still room for participants in this experiment?
"This trial, which was originally posted on November 1st 2022 and most recently modified September 9th of the same year, is no longer recruiting participants. However, 480 other clinical trials are currently in need of volunteers."
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