Actively Recruiting
A Randomized Trial of Accelerated Postoperative Radiotherapy for Intermediate- and High-risk Patients With HNSCC Initiating Radiotherapy More Than 6 Weeks After Surgery
Led by Wake Forest University Health Sciences · Updated on 2026-01-20
75
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients with intermediate- and high-risk head and neck squamous cell carcinoma (HNSCC) who have had surgery and are starting postoperative radiotherapy more than six weeks after surgery. The trial compares two radiotherapy schedules to see which better prevents cancer from returning in the treated area and improves survival while monitoring side effects and treatment timing. Eligible participants are randomly assigned to one of two groups: one group receives standard radiotherapy with five treatments per week, given daily Monday through Friday; the other group receives accelerated radiotherapy with six treatments per week, including one day with two treatments. The radiation dose is decided by the treating radiation oncologist following standard care. Participants will be closely monitored during and after treatment, including assessments of cancer recurrence, progression, survival, and side effects for up to five years. Patient-reported outcomes about symptoms and nutrition will be collected at multiple time points up to two years after radiotherapy. The total time from surgery to the end of radiotherapy and other demographic characteristics will also be recorded to understand treatment effects and safety.
CONDITIONS
Brief 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 neck lymph nodes of unknown primary
- Planned curative intent postoperative radiotherapy based on pathologic risk factors
- For non-HPV or non-oropharyngeal cancers, at least one risk factor such as pT3-4 tumor, multiple lymph nodes involved, perineural or lymphovascular invasion, close or cleared margins, extranodal extension, or positive surgical margins
- For HPV-mediated oropharyngeal cancer, at least one risk factor such as extranodal extension, positive margins, or more than 4 lymph nodes involved
- Complete macroscopic surgical removal with planned radiotherapy starting more than 42 days and no later than 112 days after surgery
- Age 18 years or older at enrollment
- ECOG performance status 0-1
- Ability to understand and sign informed consent in English or Spanish and complete study activities
You will not qualify if you...
- Recurrent head and neck cancer after prior definitive radiotherapy or surgery with postoperative radiotherapy or chemoradiotherapy
- Second primary head and neck cancer after previous treatment
- Prior radiotherapy to head and neck overlapping target area
- Active other malignancy except non-melanoma skin cancer or in situ carcinoma
- Metastatic disease outside head and neck or non-regional lymph nodes
- Time from surgery to planned radiotherapy start greater than 112 days
- Uncontrolled illness such as active infection, symptomatic heart failure, unstable angina, arrhythmia, or psychiatric/social issues limiting compliance
- Not a candidate for radiation therapy due to pregnancy or other contraindications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 6 to 7 weeks
Participants receive either accelerated or conventional postoperative radiotherapy for head and neck squamous cell carcinoma. Treatment involves daily radiation fractions 5 or 6 days per week depending on randomization.
Daily visits 5 or 6 days per week depending on treatment group
Duration - Up to 5 years post radiotherapy
Participants are monitored for survival, disease progression, and treatment-related toxicities for up to 5 years after radiotherapy ends.
Visits at end of radiotherapy, 3, 6, 12, and 24 months post radiotherapy, with additional long-term assessments
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
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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