Actively Recruiting
Postoperative Radiotherapy for Intermediate- and High-risk Patients With HNSCC Greater Than 6 Weeks After Surgery
Led by Wake Forest University Health Sciences · Updated on 2026-01-20
75
Participants Needed
3
Research Sites
258 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to determine whether accelerated radiotherapy (involving 6 treatments per week) is better than standard radiotherapy (involving 5 treatments per week) at treating cancer of the head and neck when initiated more than 6 weeks after surgery.
CONDITIONS
Official Title
Postoperative Radiotherapy for Intermediate- and High-risk Patients With HNSCC Greater Than 6 Weeks After Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed head and neck squamous cell carcinoma of the oral cavity, oropharynx, larynx, hypopharynx, sinus, or lymph nodes of the neck of unknown primary.
- Planned for curative intent postoperative radiotherapy based on pathologic risk factors.
- For non-HPV-mediated oropharyngeal or non-oropharyngeal squamous cell carcinoma, presence of at least one risk factor: pathologic tumor classification pT3-4, multiple lymph nodes involved, perineural invasion, lymphovascular invasion, close margins (within 2 mm for oropharyngeal cancer post transoral resection; within 5 mm for others) or cleared margins, extranodal extension, or positive surgical margins.
- For HPV-mediated oropharyngeal squamous cell carcinoma, presence of at least one risk factor: extranodal extension, positive surgical margins, or more than 4 lymph nodes involved.
- Complete macroscopic surgical resection with curative intent.
- Time from primary surgical resection to planned start of postoperative radiotherapy is more than 42 days but less than or equal to 112 days.
- Age 18 years or older at enrollment.
- ECOG performance status of 0-1.
- Ability and willingness to understand and sign informed consent in English or Spanish and complete study-related activities.
You will not qualify if you...
- Recurrent head and neck cancer after prior definitive radiotherapy or surgery followed by postoperative radiotherapy or chemoradiotherapy.
- Second primary head and neck cancer after prior treatment.
- Prior radiotherapy to the head and neck that overlaps with planned treatment area.
- Active malignancy other than the head and neck cancer being treated, excluding non-melanoma skin cancer and in situ carcinoma.
- Metastatic disease beyond the head and neck region.
- Time from primary surgery to planned postoperative radiotherapy start greater than 112 days.
- Uncontrolled illness such as active infection, heart failure, unstable angina, arrhythmia, or psychiatric/social conditions limiting compliance.
- Not a candidate for radiation therapy, including pregnancy or other contraindications.
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Levine Cancer Institute
Charlotte, North Carolina, United States, 28204
Actively Recruiting
2
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
3
Advocate Aurora Radiation Oncology
Milwaukee, Wisconsin, United States, 53215
Actively Recruiting
Research Team
R
Ryan Hughes, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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