HPV DNA-Guided Radiotherapy De-intensification of Head and Neck Squamous Cell Carcinoma
HN001
Circulating Tumor Modified HPV DNA-Guided Radiotherapy De-intensification of the Elective Neck (RaDEN) in Squamous Cell Carcinoma of the Head and Neck
1 other identifier
interventional
90
1 country
5
Brief Summary
The study will evaluate the safety and effectiveness of a lower than standard dose of radiation for definitive or adjuvant treatment of head and neck squamous cell carcinomas.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2024
Longer than P75 for phase_2
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 30, 2023
CompletedFirst Posted
Study publicly available on registry
July 27, 2023
CompletedStudy Start
First participant enrolled
June 28, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2029
February 5, 2026
February 1, 2026
3.3 years
June 30, 2023
February 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Incidence of disease free survival as measured by circulating HPV on Nav Dx blood tests.
up to 2 years after radiotherapy
Secondary Outcomes (3)
To assess safety for treatment with reduced dose and volume-de-escalated radiotherapy to the neck
Evaluated through 6 months and 1 year post- radiation.
To estimate quality of life of participants who receive reduced dose and volume-de-escalated radiotherapy to the neck
up to 2 years after radiotherapy
To estimate quality of life of participants who receive reduced dose and volume-de-escalated radiotherapy to the neck
up to 2 years after radiotherapy
Other Outcomes (3)
To estimate long-term survival for participants treated with dose and volume-de-escalated radiotherapy to the neck
up to 5 years after radiotherapy
To estimate the relationship between baseline lymphocyte counts and disease progression outcomes.
up to 2 years after radiotherapy
To estimate the relationship between baseline lymphocyte counts and disease progression
up to 2 years after radiotherapy
Study Arms (4)
Reduce Dose without Concurrent Chemotherapy Non- Rapid Responder
EXPERIMENTALA 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.
Reduce Dose with Concurrent Chemotherapy Non-Rapid Responder
EXPERIMENTALA 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.
Reduce Dose without Concurrent Chemotherapy Rapid Responder
EXPERIMENTALA reduced dose regimen of 24 Gy in 12 fractions to gross disease and intermediate nodes. Then 36 Gy in 18 fractions to entire volume.
Reduce Dose with Concurrent Chemotherapy Rapid Responder
EXPERIMENTALA reduced dose regimen of 24 Gy in 12 fractions to gross disease and intermediate nodes. Then 30 Gy in 15 fractions to entire volume.
Interventions
External Beam Radiation to Head and Neck
Eligibility Criteria
You may qualify if:
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, ≥ 18 years of age
- Pathologically proven diagnosis of squamous cell carcinoma of the oropharynx of any AJCC 8th edition stage.
- Eligible for and planning to receive definitive treatment or adjuvant treatment with radiotherapy.
- Participants who are receiving concurrent systemic anticancer therapy (e.g. chemotherapy or immunotherapy) for oropharyngeal cancer are eligible.
- For participants with T1-2 and N0 disease, chemotherapy is not required for eligibility. Participants may or may not receive chemotherapy per physician discretion.
- For participants with T3-4 and/or N+ disease, chemotherapy is required for eligibility.
- Participants may receive investigational agents with prior approval from the Principal Investigator.
- ECOG Performance Status of 0-2.
- p16 positive HPV as determined by NavDx and immunohistochemistry
- For females of reproductive potential: agreement to use adequate contraception during radiation treatment and for 6 months (or more if applicable based on other medications) after the end of radiation treatment.
You may not qualify if:
- Evidence of distant metastatic disease
- Prior history of radiotherapy to the head and/or neck
- Had surgery for oropharyngeal cancer within 8 months of enrollment unless it was an incomplete oncologic surgery. Participant is eligible if the gross tumor was not completely removed.
- Diagnosis of T3-4 and/or N+ disease with no plans to receive concurrent chemotherapy.
- Diagnosis of a current or prior invasive malignancy (except non-melanoma skin cancer) unless the participant has been disease free for at least 3 years.
- Participant is a prisoner
- Known contraindications to head and neck radiation therapy such as ataxia telangiectasia or scleroderma.
- Pregnancy or lactation
- Active or severe co-morbidities as defined by the following:
- Unstable angina and/or congestive heart failure requiring hospitalization up to 180 days before registration
- Transmural myocardial infarction up to 180 days before registration
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
- Hepatic insufficiency as determined by the treating clinician resulting in clinical jaundice and/or coagulation effects or severe liver dysfunction.
- Acquired immune deficiency syndrome (AIDS) based upon current CDC definition. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be slightly immunosuppressive. Protocol-specific requirements may also exclude immuno-compromised patients.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Miami Cancer Institute
Miami, Florida, 33176, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
Eastern Virginia Medical School
Norfolk, Virginia, 23507, United States
Bon Secours
Richmond, Virginia, 23114, United States
Virginia Commonwealth University
Richmond, Virginia, 23284, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chris McLaughlin, M.D.
UVA
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Radiation Oncology
Study Record Dates
First Submitted
June 30, 2023
First Posted
July 27, 2023
Study Start
June 28, 2024
Primary Completion (Estimated)
November 1, 2027
Study Completion (Estimated)
November 1, 2029
Last Updated
February 5, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share