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Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Phase 2NCT07178301

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

A Phase 2 study testing Computed Tomography, Nasopharyngeal Laryngoscopy and Positron Emission Tomography in people with Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 and Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, run by Northwestern University at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Computed Tomography, Nasopharyngeal Laryngoscopy and Positron Emission Tomography
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
2 sitesUnited States
Study dates
5 Dec 2025to 20 Mar 2031
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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.

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Study Coordinator contact

312-695-1301

cancer@northwestern.edu

United States2 sites, 2 recruiting

  • Northwestern University

    Chicago, Illinois, 60611

    Laila A. Gharzai, 312-694-6835, laila.gharzai@northwestern.edu

    Laila A. Gharzai

    Recruiting

  • Northwestern Medicine Warrenville

    Warrenville, Illinois, 60555

    Laila Gharzai, MD, 312-694-6835, cancer@northwestern.edu

    Recruiting

Other trials in United States

About this study

Official title: 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

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To determine 2-year locoregional progression free survival (LRPFS).

SECONDARY OBJECTIVES:

  1. 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).
  2. 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.

Being tested
Computed Tomography, Nasopharyngeal Laryngoscopy, Positron Emission Tomography, Questionnaire Administration, Radiation Therapy
Medical subject headings
Oropharyngeal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT

  • Nasopharyngeal LaryngoscopyProcedure or surgery

    Undergo nasopharyngolaryngoscopy

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)

    Undergo PET

  • Questionnaire AdministrationOther

    Ancillary studies

  • Radiation TherapyRadiation

    Also called Cancer Radiotherapy, Energy Type, ENERGY_TYPE, Irradiate

    Undergo radiation therapy

Study groups in NCT07178301
Study groupRoleWhat they receive
Treatment (radiation therapy)ExperimentalPatients 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.
Receives: Procedure: Computed Tomography; Procedure: Nasopharyngeal Laryngoscopy; Procedure: Positron Emission Tomography; Other: Questionnaire Administration; Radiation: Radiation Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 2-year locoregional progression free survival

    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.

    Measured: 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

Secondary outcomes (5)

  1. 2-year PFS

    Will be analyzed using the Kaplan-Meier method. Differences in survival distributions across patient subgroups will be evaluated using log-rank tests, and Cox models will be used to explore the effects of demographic and clinical variables on PFS.

    Measured: From the beginning of radiation therapy to the first incidence of local recurrence, regional recurrence in the neck, distant metastasis, or death, assessed at 2 years post-treatment

  2. 2-year regional failure in the low-dose elective neck region

    This will be assessed by comparing regional failures with the prior radiation plan, by overlaying radiation dose delivered to the area of nodal failure. Nodal failures in the 30 Gy volume will be considered elective neck failures.

    Measured: At 2 years post-treatment

  3. 2-year overall survival (OS)

    Will be analyzed using the Kaplan-Meier method. Log-rank tests and Cox proportional hazards models may be used to explore differences in OS by covariates such as age, sex, and baseline disease severity when appropriate.

    Measured: From the beginning of radiation therapy to death from any cause, assessed at 2 years post-treatment

  4. Incidence of physician-reported adverse events (AEs)

    Will be measured by Common Terminology Criteria for Adverse Events version 6.0. Will generate adverse event summaries, which will include maximum grade and frequency, based on the National Cancer Institute Common Terminology Criteria for Adverse Events version 6.0. AEs will be graded as mild, moderate, severe, or life-threatening. All reported toxicities will be summarized by toxicity type and maximum grade, and sorted by the number of patients experiencing each toxicity. For each patient, the maximum grade of a given toxicity will be determined across all timepoints. AE data will be presented using categorical analyses and descriptive summary statistics. No formal statistical hypothesis testing will be performed.

    Measured: At 1, 3, and 12 months post-treatment

  5. Incidence of patient-reported adverse events

    Will be measured by Functional Assessment of Cancer Therapy - Head \& Neck Radiotherapy Index.

    Measured: At 1, 3, and 12 months post-treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2025
  2. Study start5 Dec 2025
  3. Primary completion20 Mar 2030 (estimated)
  4. Study completion20 Mar 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Patients will undergo standard of care treatment with definitive radiotherapy, to a dose of 70 Gy to gross tumor (per standard of care) and 30 Gy to the elective neck.
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07178301
Sponsor's protocol ID
NU 25N01
Other IDs
NCI-2025-06273, STU00224657, NU 25N01, P30CA060553
Status last verified
Jul 2026
First submitted
10 Sep 2025
Last updated
14 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Computed Tomography, Nasopharyngeal Laryngoscopy and Positron Emission Tomography in people with Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 and Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, run by Northwestern University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Study Coordinator (312-695-1301, cancer@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07178301.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.

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