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Radiation Therapy
Reduced-Dose Radiotherapy for Head and Neck Cancer (HART-HN Trial)
N/A
Recruiting
Led By Musaddiq Awan, 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
Patients must have at least 1 of the following intermediate risk factors for adjuvant radiation: Pathologic Node Positive Disease, Perineural Invasion, Oral cavity cancer with depth of invasion of at least 5 mm, Lymphovascular Space Invasion, Pathologic T3 or T4 disease
Patients 18 years or older with gross totally resected (R0 resection) Human papillomavirus (HPV) -negative squamous cell carcinoma of the head and neck
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights
HART-HN Trial Summary
This trial will test if it is safe to reduce the amount of radiation therapy given to head and neck cancer patients with intermediate pathologic risk features.
Who is the study for?
Adults with certain types of head and neck cancers that have been surgically removed but carry intermediate risk factors for recurrence. Participants must be in good general health, psychologically able to complete the study, not pregnant or breastfeeding, willing to use contraception if of childbearing potential, and without recent serious heart issues or other invasive malignancies.Check my eligibility
What is being tested?
The trial is testing three different doses of radiation therapy (42 Gy, 39 Gy, and 32.5 Gy) given over fewer treatment sessions than usual to see which is safest for patients with resected head and neck squamous cell carcinoma who are at an intermediate risk of cancer returning.See study design
What are the potential side effects?
Radiation therapy may cause side effects such as skin irritation at the treatment site, fatigue, dry mouth or throat discomfort due to inflammation in treated areas. Long-term risks include possible changes in skin texture or coloration and a slight increase in the chance of developing another cancer.
HART-HN Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has one of the specific risk factors like spreading to lymph nodes or deep growth.
Select...
I am 18 or older and had surgery to completely remove HPV-negative squamous cell carcinoma in my head or neck.
Select...
I can take care of myself and am up and about more than 50% of my waking hours.
HART-HN Trial 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
Incidence of Dose-Limiting Toxicities
Maximum-tolerated Radiation Dose
Secondary outcome measures
Functional Assessment of Cancer Therapies- Head and Neck (Emotional Well-being)
Functional Assessment of Cancer Therapies- Head and Neck (FACT-HN)
Functional Assessment of Cancer Therapies- Head and Neck (Functional Well-being)
+9 moreHART-HN Trial Design
3Treatment groups
Experimental Treatment
Group I: 42 Gray (Gy) RadiationExperimental Treatment1 Intervention
42 gy of radiation therapy will be administered in 10 fractions.
Group II: 39 Gray (Gy) RadiationExperimental Treatment1 Intervention
39 gy of radiation therapy will be administered in 8 fractions.
Group III: 32.5 Gray (Gy) RadiationExperimental Treatment1 Intervention
32.5 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
Musaddiq Awan, MDPrincipal InvestigatorMedical College of Wisconsin
1 Previous Clinical Trials
18 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a woman who is either postmenopausal, surgically sterile, or willing to use two forms of birth control.My cancer has one of the specific risk factors like spreading to lymph nodes or deep growth.I haven't been hospitalized for heart issues in the last 3 months.I am 18 or older and had surgery to completely remove HPV-negative squamous cell carcinoma in my head or neck.I am not pregnant and willing to use contraception during and 6 months after treatment.I have had radiation therapy to my head or neck.My body weight is 30 kg or less.I had a major heart attack in the last 3 months.My surgery left some cancer cells behind.My cancer has spread outside the lymph nodes.My cancer is HPV-positive squamous cell carcinoma.I am mentally and physically able to follow the study's requirements.I haven't had cancer (except skin or early prostate cancer) in the last 3 years.I am a male and agree to follow the study's rules on preventing pregnancy.I have received systemic therapy for my cancer.I can take care of myself and am up and about more than 50% of my waking hours.
Research Study Groups:
This trial has the following groups:- Group 1: 32.5 Gray (Gy) Radiation
- Group 2: 42 Gray (Gy) Radiation
- Group 3: 39 Gray (Gy) Radiation
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.
Are investigators currently enrolling participants in this research experiment?
"Affirmative. Clinicaltrials.gov's data reveals that this clinical trial is recruiting patients, with the initial post having been made on December 1st 2021 and last updated on Christmas day of the same year. 18 participants need to be sourced from a single medical centre for the study to reach completion."
Answered by AI
How many participants are currently being accepted into this research project?
"Affirmative. According to clinicaltrials.gov, this medical trial is actively recruiting participants with the first post date of December 1st 2021 and a most recent update on Christmas Day 2021. At present 18 patients need to be sourced from one site for enrolment into the study."
Answered by AI
What primary goals has this clinical trial been designed to achieve?
"This clinical trial will assess the Incidence of Dose-Limiting Toxicities over a 12 month period, with secondary outcome metrics such as MD Anderson Dysphagia Inventory Composite Score (a 19 question Likert scale), Functional Assessment of Cancer Therapies- Head and Neck (FACT-HN) score range from 0 to 28 with lower scores indicating better quality of life, and Physical Well being sub scales ranging from 0 to 4."
Answered by AI
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