A Randomized Trial of Accelerated Postoperative Radiotherapy for Intermediate- and High-risk Patients With HNSCC (Head and Neck Squamous Cell Carcinoma) Initiating Radiotherapy Greater Than 6 Weeks After Surgery (PORTRush)
Wake Forest University Health Sciences
Summary
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.
Description
This study is a randomized trial designed to determine the effect of Accelerated Fractionation (AF) versus Conventional Fractionation (CF) PORT on locoregional recurrence-free survival, progression-free survival, overall survival, toxicity, and treatment package time in participants with resected intermediate and high-risk Head and Neck Squamous Cell Carcinoma (HNSCC) planned to start Post Operative Radiotherapy (PORT) greater than six weeks after surgery. Eligible participants in both cohorts will be randomized 1:1 to receive five fractions per week of standard conventional fractionation radi…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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. * Patients with non-HPV-mediated oropharyngeal squamous cell carcinoma or non-oropharyngeal squamous cell carcinoma must have at least one of the following: pathologic tumor classification pT3-4, multiple lymph nodes involved with cancer, perineural invasion, lymphovascular invasion, close margins (within 2 mm f…
Interventions
- RadiationAccelerated radiotherapy
6 fractions per week, BID fractions one day per week
- RadiationConventional radiotherapy
5 fractions per week, daily M-F
Locations (3)
- Levine Cancer InstituteCharlotte, North Carolina
- Wake Forest Baptist Comprehensive Cancer CenterWinston-Salem, North Carolina
- Advocate Aurora Radiation OncologyMilwaukee, Wisconsin