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Radiation
Reduced-Dose Radiotherapy for Head and Neck Cancer (HN001 Trial)
Phase 2
Waitlist Available
Led By Chris McLaughlin, M.D.
Research Sponsored by University of Virginia
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 2 years after radiotherapy
Awards & highlights
HN001 Trial Summary
This trial will test if a lower dose of radiation is just as safe and effective for treating head and neck cancer.
Who is the study for?
This trial is for adults with HPV-positive squamous cell carcinoma of the oropharynx. They must be willing to use contraception, follow study procedures, and can receive other cancer treatments if approved. Excluded are those with distant metastasis, recent heart issues, severe infections or lung problems, liver dysfunction, AIDS, heavy tobacco history unless quit a year ago, current antineoplastic drug use for another cancer, prior head/neck radiation or another invasive malignancy within 3 years.Check my eligibility
What is being tested?
The trial tests a lower dose of radiation therapy on patients with head and neck squamous cell carcinomas to see if it's as effective and safer than standard doses. It includes people getting concurrent chemotherapy or immunotherapy for their condition.See study design
What are the potential side effects?
Radiation therapy may cause skin irritation at the treatment site, fatigue, dry mouth or throat discomfort due to mucosal inflammation; potential long-term effects include changes in taste sensation and difficulty swallowing.
HN001 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years after radiotherapy
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years after radiotherapy
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To assess the disease control of participants who receive dose and volume-de-escalated radiotherapy to the neck, guided by treatment response through circulating tumor-modified HPV DNA testing
Secondary outcome measures
To assess safety for treatment with reduced dose and volume-de-escalated radiotherapy to the neck
To estimate quality of life of participants who receive reduced dose and volume-de-escalated radiotherapy to the neck
Other outcome measures
To estimate long-term survival for participants treated with dose and volume-de-escalated radiotherapy to the neck
To estimate the relationship between baseline lymphocyte counts and disease progression
To estimate the relationship between baseline lymphocyte counts and disease progression outcomes.
HN001 Trial Design
4Treatment groups
Experimental Treatment
Group I: Reduce Dose without Concurrent Chemotherapy Rapid ResponderExperimental Treatment1 Intervention
A reduced dose regimen of 24 Gy in 12 fractions to gross disease and intermediate nodes. Then 36 Gy in 18 fractions to entire volume.
Group II: Reduce Dose without Concurrent Chemotherapy Non- Rapid ResponderExperimental Treatment1 Intervention
A reduced dose regimen of 24 Gy in 12 fractions to gross disease and intermediate nodes. Then 36 Gy in 18 fractions to entire volume. Non-responders will receive an additional boost of 10 Gy in 5 fractions to entire volume.
Group III: Reduce Dose with Concurrent Chemotherapy Rapid ResponderExperimental Treatment1 Intervention
A reduced dose regimen of 24 Gy in 12 fractions to gross disease and intermediate nodes. Then 30 Gy in 15 fractions to entire volume.
Group IV: Reduce Dose with Concurrent Chemotherapy Non-Rapid ResponderExperimental Treatment1 Intervention
A reduced dose regimen of 24 Gy in 12 fractions to gross disease and intermediate nodes. Then 30 Gy in 15 fractions to entire volume. Non-responders will receive an additional boost of 10 Gy in 5 fractions to entire volume.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation Therapy
2017
Completed Phase 3
~7250
Find a Location
Who is running the clinical trial?
University of VirginiaLead Sponsor
753 Previous Clinical Trials
1,244,941 Total Patients Enrolled
Chris McLaughlin, M.D.Principal InvestigatorUVA
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am planning to undergo radiotherapy as my main or additional cancer treatment.I am able to get out of my bed or chair and move around.My cancer has spread to distant parts of my body.I do not have conditions like ataxia telangiectasia or scleroderma that prevent head and neck radiation.I am 18 years old or older.I have been diagnosed with squamous cell carcinoma in the throat.I have early-stage cancer and may not need chemotherapy.I agree to use birth control during and for 6 months after my radiation treatment.I need chemotherapy to join because my cancer is advanced or has spread to lymph nodes.I am currently receiving treatment for oropharyngeal cancer.My cancer is HPV-positive as confirmed by specific tests.My cancer is advanced but I'm not planning to have chemotherapy with other treatments.I had surgery for throat cancer less than 8 months ago.I have been cancer-free for at least 3 years, except for non-melanoma skin cancer.I have had radiation therapy to my head or neck before.
Research Study Groups:
This trial has the following groups:- Group 1: Reduce Dose without Concurrent Chemotherapy Non- Rapid Responder
- Group 2: Reduce Dose with Concurrent Chemotherapy Non-Rapid Responder
- Group 3: Reduce Dose without Concurrent Chemotherapy Rapid Responder
- Group 4: Reduce Dose with Concurrent Chemotherapy Rapid Responder
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 many different sites are currently managing this trial?
"This clinical trial is currently enrolling from 4 different sites, which are located in Charlottesville, Norfolk and Richmond as well as other locales. It may be beneficial to select the closest site in order to minimize transport needs should you choose to participate."
Answered by AI
Is enrollment still taking place for this clinical trial?
"Per the information found on clinicaltrials.gov, this particular trial is no longer enrolling patients. It was initially posted in September of 2023 and updated as recently as July 22nd of that same year; yet despite its recent activity, 2647 other medical trials are actively searching for applicants right now."
Answered by AI
What safety considerations should be taken into account when administering Reduced Dose without Concurrent Chemotherapy Non- Rapid Responder to patients?
"Based on our internal assessment, the safety of Reduce Dose without Concurrent Chemotherapy Non- Rapid Responder has been rated a 2. This is due to there being existing data that suggest its security but none indicating efficacy."
Answered by AI
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