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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Northwestern University
Study ID
NCT07178301
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Dec 5, 2025
Status verified
Jun 2025
Primary completion
Mar 20, 2030
Completion
Mar 20, 2031

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (radiation therapy)
    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 CT, PET, and nasopharyngolaryngoscopy throughout the trial.

Primary Outcome Measure

2-year locoregional progression free survival [ Time Frame: From the beginning of radiation therapy to the first incidence of local recurrence, regional recurrence in the neck, or death, assessed at 2 years post-treatment ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Northwestern UniversityChicagoIllinois60611
Laila A. Gharzai
[email protected]
312-694-6835
Laila A. Gharzai (PRINCIPAL_INVESTIGATOR)
Northwestern Medicine WarrenvilleWarrenvilleIllinois60555
Laila Gharzai, MD
[email protected]
312-694-6835

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By research site
Northwestern University· Chicago, ILNorthwestern Medicine Warrenville· Warrenville, IL

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