Status:
NOT_YET_RECRUITING
Evaluating a Decreased Dose of Radiation Therapy to the Elective Neck for the Treatment of HPV-Related Oropharyngeal Cancer, ENLIGHT Trial
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 pap...
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 regio...
Eligibility Criteria
Inclusion
- Patients must have a histologically confirmed HPV-related OPSCC, confirmed by HPV in-situ hybridization
- Patients must not have received prior treatment (i.e., no induction chemotherapy)
- Patients must have evaluable disease (per Response Evaluation Criteria in Solid Tumors \[RECIST\] version \[v\]1.1 response criteria)
- Patients must be age \>= 18 years
- Patients must have American Joint Committee on Cancer (AJCC) 8th 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)
- Patient must receive a staging PET scan prior to registration on study
- Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Patients may be planned to undergo radiation therapy (RT) alone or RT with concurrent chemotherapy, with chemotherapy managed at the discretion of the treating medical oncologist per standard of care
- 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; 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 or her partner is participating in this study, she should inform her treating physician immediately.
- 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)
- POCBP must have a negative pregnancy test prior to CT simulation or sign the Department of Radiation Oncology's pregnancy testing declination form
- Note: the timing of the pregnancy test/declination form will follow the policy of the Department of Radiology and Oncology, which requires completion of pregnancy testing or signed pregnancy declination prior to CT simulation
- Patients must have the ability to understand and the willingness to sign a written informed consent document prior to registration
Exclusion
- Patients with cT4, cN3, or cM1 disease by AJCC 8th edition
- Patients who have had prior RT to the head/neck region that would result in overlap of RT fields
- Patients who have had prior major surgery to the head/neck region that could disrupt lymphatic flow
- 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
Key Trial Info
Start Date :
March 20 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 20 2031
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT07178301
Start Date
March 20 2026
End Date
March 20 2031
Last Update
September 17 2025
Active Locations (1)
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1
Northwestern University
Chicago, Illinois, United States, 60611