NCT07178301

Evaluating a Decreased Dose of Radiation Therapy to the Elective Neck for the Treatment of HPV-Related Oropharyngeal Cancer, ENLIGHT Trial

Elective Neck Dosing in Low Risk Oropharyngeal Human Papillomavirus-Related Cancer Treatment (ENLIGHT): A Single Arm Prospective Phase II Assessing 30 Gy Elective Neck Dose

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial evaluates how decreasing the dose of radiation to the elective neck (areas of lymph nodes not directly involved in the cancer) impacts treatment outcomes in patients with human papillomavirus (HPV)-related oropharyngeal cancer. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Radiation therapy plays an important role in the treatment of HPV-related oropharyngeal cancer, but it also causes significant toxicities. Given the significant toxicities associated with treatment, and the excellent outcomes of HPV-related oropharyngeal cancer, researchers are attempting to identify methods to de-escalate treatment for HPV-related oropharyngeal cancer in an effort to maintain excellent treatment outcomes while reducing the risk of toxicities. Reducing the dose of radiation therapy to the lymph nodes in the neck that aren't directly involved in the cancer may improve patient quality of life while still maintaining excellent rates of cure of disease.

Detailed description

PRIMARY OBJECTIVE: I. To determine 2-year locoregional progression free survival (LRPFS). SECONDARY OBJECTIVES: I. To determine 2-year progression free survival (PFS). II. To determine 2-year regional failure in the low-dose elective region. III. To determine 2-year overall survival (OS). IV. To determine physician-reported toxicities at 1, 3, 12-months as measured by Common Terminology Criteria for Adverse Events (CTCAE). V. To assess patient-reported toxicities at 1, 3, 12-months as measured by Functional Assessment of Cancer Therapy - Head \& Neck Radiotherapy Index (FACT-HN-Rad). OUTLINE: Patients 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. Patients also undergo computed tomography (CT), positron emission tomography (PET), and nasopharyngolaryngoscopy throughout the trial. After completion of study treatment, patients are followed up every 3 months for 2 years.

Conditions

• Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
• Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8

Interventions

Type	Name	Description
PROCEDURE	Computed Tomography	Undergo CT
PROCEDURE	Nasopharyngeal Laryngoscopy	Undergo nasopharyngolaryngoscopy
PROCEDURE	Positron Emission Tomography	Undergo PET
OTHER	Questionnaire Administration	Ancillary studies
RADIATION	Radiation Therapy	Undergo radiation therapy

Timeline

• Start date: 2026-03-20
• Primary completion: 2030-03-20
• Completion: 2031-03-20
• First posted: 2025-09-17
• Last updated: 2025-09-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study