Actively Recruiting
Elective Neck Dosing in Low Risk Oropharyngeal HPV-Related Cancer Treatment ENLIGHT Trial Assessing 30 Gy Elective Neck Dose
Led by Northwestern University · Updated on 2026-06-08
100
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
Sponsors
N
Northwestern University
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating how lowering the radiation dose to certain lymph nodes in the neck affects treatment results in patients with human papillomavirus (HPV)-related oropharyngeal cancer. This cancer type generally has excellent outcomes, but radiation therapy often causes significant side effects. The goal is to find ways to reduce treatment intensity to maintain good cancer control while lessening toxic effects and improving quality of life. In this study, patients receive standard radiation doses to the main tumor and a reduced dose to the elective neck lymph nodes not directly involved in cancer. Radiation is given five days a week for 7 weeks, totaling 35 treatment sessions. During the trial, patients undergo procedures such as computed tomography (CT), positron emission tomography (PET), and nasopharyngolaryngoscopy to monitor their condition. After treatment, participants are followed every 3 months for 2 years to assess outcomes. Researchers measure progression-free survival, regional failure in low-dose areas, overall survival, and side effects reported by doctors and patients at multiple time points. Patient quality of life and toxicity are tracked using specialized questionnaires and clinical evaluations to understand the impact of the lowered radiation dose.
CONDITIONS
Brief Title
Evaluating a Decreased Dose of Radiation Therapy to the Elective Neck for the Treatment of HPV-Related Oropharyngeal Cancer, ENLIGHT Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have histologically confirmed HPV-related oropharyngeal squamous cell carcinoma confirmed by HPV in situ hybridization
- No prior treatment for the cancer, including no induction chemotherapy
- Patients must have measurable disease per RECIST v1.1 criteria
- Age 18 years or older
- AJCC 8th edition Stage I-II disease with T1-3 and N1-2 classification without metastases (M0)
- Must have a staging PET scan before enrollment
- ECOG performance status of 0 or 1
- Planned to undergo radiation therapy alone or with concurrent chemotherapy
- Patients of child-bearing potential must agree to use effective contraception during the study
- Negative pregnancy test prior to CT simulation or signed declination form
- Ability to understand and sign informed consent
You will not qualify if you...
- Patients with cT4, cN3, or metastatic (cM1) disease by AJCC 8th edition
- Prior radiation therapy to head or neck causing overlapping treatment fields
- Prior major surgery to head or neck disrupting lymphatic flow
- Uncontrolled illnesses that interfere with radiation therapy such as connective tissue disorders or psychiatric/social issues limiting compliance
- Any other illness or condition that may compromise safety or study participation as judged by the investigator
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 - 7 weeks
Participants receive standard dose radiation therapy to the tumor and reduced dose radiation therapy to the elective neck lymph nodes five days per week for a total of 35 fractions over 7 weeks. Participants also undergo CT, PET, and nasopharyngolaryngoscopy throughout the treatment period.
Daily visits for radiation therapy 5 days per week and additional imaging visits during treatment
Duration - 2 years
Participants are followed up every 3 months for 2 years after completing treatment to monitor survival and toxicities.
Quarterly visits every 3 months for 2 years
Trial Site Locations
Total: 2 locations
1
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
2
Northwestern Medicine Warrenville
Warrenville, Illinois, United States, 60555
Actively Recruiting
Research Team
S
Study Coordinator
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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