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ENLIGHT Trial: Reduced Radiation for HPV-Related Oropharyngeal Cancer

This study, called the ENLIGHT Trial, is looking at a new way to treat HPV-related oropharyngeal cancer (a type of throat cancer linked to the human papillomavirus). Researchers are testing if giving a lower dose of radiation therapy to the "elective neck" (lymph nodes in the neck that aren't directly cancerous but are at risk) can still be effective while causing fewer side effects. You might be able to join if you have newly diagnosed HPV-related oropharyngeal cancer, confirmed by a test called HPV in-situ hybridization, and have not had prior treatment. The main goal is to see how many patients are free from cancer returning in the treated area after two years. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 100 participants. The phase of the study is not specified.
What's involved
You would receive radiation therapy five days a week for 7 weeks. You would also undergo CT scans, PET scans, and nasopharyngolaryngoscopy procedures throughout the trial.
Compensation
Not stated in the trial record.
Follow-up
After treatment, you would be followed up every 3 months for 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07178301

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Northwestern University
~100 participants
Updated 2026-07-14 on ClinicalTrials.gov
What's tested:Computed TomographyNasopharyngeal LaryngoscopyPositron Emission TomographyQuestionnaire AdministrationRadiation Therapy

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
2-year locoregional progression free survival
Measured over 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

Conditions

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

Explore related trials

Oropharyngeal CarcinomaCDKN2A wt AlleleHPV

Where it's being run

2 sites across 1 states
Illinois2

Study leadership

  • Laila A Gharzai · PRINCIPAL_INVESTIGATOR · Northwestern University

Who to contact

Study Coordinator
[email protected]
312-695-1301
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

3.1.1 Patients must have a histologically confirmed HPV-related OPSCC, confirmed by HPV insitu hybridization.
3.1.2 Patients must not have received prior treatment (i.e., no induction chemotherapy).
3.1.3 Patients must have evaluable disease (per RECIST v1.1 response criteria). See Section 6.
3.3 for the evaluation of measurable disease.
3.1.4 Patients must be age ≥ 18 years.
3.1.5 Patients must have AJCC 8 th edition Stage I-II disease, as defined by a T-classification of T1-3, and N-classification of N1-2, without metastases (M0), as defined by physical examination (including nasopharyngolaryngoscopy) and positron emission tomography (PET).
3.1.6 Patient must receive a staging PET scan prior to registration on study.
3.1.7 Patients must exhibit an ECOG performance status of 0-1. Please refer to Appendix A ECOG Performance Status Scale.
3.1.8 Patients may be planned to undergo RT alone or RT with concurrent chemotherapy, with chemotherapy managed at the discretion of the treating medical oncologist per standard of care.
3.1.9 RT is known to be teratogenic to a developing human fetus. For this reason, patients of child-bearing potential (POCBP) must agree to use adequate contraception (hormonal or barrier method of birth control; surgical methods (e.g. tubal ligation); abstinence) from time of informed consent, for the duration of study participation (while actively receiving RT. Should a patient become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately for consideration of cessation of RT. NOTE: A POCBP is any patient (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: • Has not undergone a hysterectomy or bilateral oophorectomy • Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for \> 12 months)
3.1.10 POCBP must have a negative pregnancy test prior to CT simulation or sign the Department of Radiation Oncology's standard pregnancy testing declination form. Note: the timing of the pregnancy test/declination form will follow the standard policy of the Department of Radiation Oncology, which requires completion of pregnancy testing or signed pregnancy declination prior to CT simulation.
3.1.11 Patients must have the ability to understand and the willingness to sign a written informed consent document prior to registration.

Exclusion

3.2.1 Patients with cT4, cN3, or cM1 disease by AJCC 8 th edition.
3.2.2 Patients who have had prior RT to the head/neck region that would result in overlap of RT fields.
3.2.3 Patients who have had prior major surgery to the head/neck region that could disrupt lymphatic flow as determined by the PI.
3.2.4 Patients who have an uncontrolled intercurrent illness that would interfere with the receipt of RT including, but not limited to any of the following, are not eligible: • Uncontrolled connective tissue disorders (e.g. lupus, scleroderma) given potential for this to interfere with RT • Psychiatric illness/social situations that would limit compliance with study requirements • Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient's safety or study endpoints

What this trial measures

  • 2-year locoregional progression free survivalFrom 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

    Response Evaluation Criteria in Solid Tumors version 1.1 will be used to assess tumor response. The 2-year progression free survival (PFS) estimate will be reported along with the confidence interval. Log-rank tests will be used to compare PFS across predefined subgroups. Cox proportional hazards models will be applied to assess the impact of covariates such as age, sex, baseline disease severity on PFS, when appropriate.