[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07178301":3,"trial-entities:NCT07178301":176,"trial-summary:NCT07178301":182},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":87,"secondary_outcomes":92,"sex":112,"minimum_age":113,"maximum_age":114,"healthy_volunteers":115,"eligibility_criteria":116,"std_ages":136,"locations":139,"central_contacts":167,"overall_officials":171,"references":174,"see_also_links":175},"NCT07178301","NU 25N01","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","RECRUITING","2031-03-20","2026-07","2026-07-14","2025-12-05","Northwestern University","OTHER",true,"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.","PRIMARY OBJECTIVE:\n\nI. To determine 2-year locoregional progression free survival (LRPFS).\n\nSECONDARY OBJECTIVES:\n\nI. 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).\n\nV. 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).\n\nOUTLINE:\n\nPatients 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.\n\nAfter completion of study treatment, patients are followed up every 3 months for 2 years.",[19,20],"Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8","Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8",[],"INTERVENTIONAL","TREATMENT",[25],"PHASE2",{"count":27,"type":28},100,"ESTIMATED",[30,49,53,65,69],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":36},"PROCEDURE","Computed Tomography","Undergo CT",[35],"Treatment (radiation therapy)",[37,38,39,40,41,42,43,44,45,46,47,48],"CAT","CAT Scan","Computed Axial Tomography","Computerized Axial Tomography","Computerized axial tomography (procedure)","Computerized Tomography","Computerized Tomography (CT) scan","CT","CT Scan","Diagnostic CAT Scan","Diagnostic CAT Scan Service Type","tomography",{"type":31,"name":50,"description":51,"armGroupLabels":52},"Nasopharyngeal Laryngoscopy","Undergo nasopharyngolaryngoscopy",[35],{"type":31,"name":54,"description":55,"armGroupLabels":56,"otherNames":57},"Positron Emission Tomography","Undergo PET",[35],[58,59,60,61,62,63,64],"Medical Imaging, Positron Emission Tomography","PET","PET Scan","Positron emission tomography (procedure)","Positron Emission Tomography Scan","Positron-Emission Tomography","PT",{"type":14,"name":66,"description":67,"armGroupLabels":68},"Questionnaire Administration","Ancillary studies",[35],{"type":70,"name":71,"description":72,"armGroupLabels":73,"otherNames":74},"RADIATION","Radiation Therapy","Undergo radiation therapy",[35],[75,76,77,78,79,80,81,82,83,84,85,86],"Cancer Radiotherapy","Energy Type","ENERGY_TYPE","Irradiate","Irradiated","Irradiation","Radiation","Radiation Therapy, NOS","Radiotherapeutics","Radiotherapy","RT","Therapy, Radiation",[88],{"measure":89,"description":90,"timeFrame":91},"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.","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",[93,97,101,105,109],{"measure":94,"description":95,"timeFrame":96},"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.","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",{"measure":98,"description":99,"timeFrame":100},"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.","At 2 years post-treatment",{"measure":102,"description":103,"timeFrame":104},"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.","From the beginning of radiation therapy to death from any cause, assessed at 2 years post-treatment",{"measure":106,"description":107,"timeFrame":108},"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.","At 1, 3, and 12 months post-treatment",{"measure":110,"description":111,"timeFrame":108},"Incidence of patient-reported adverse events","Will be measured by Functional Assessment of Cancer Therapy - Head \\& Neck Radiotherapy Index.","ALL","18 Years",null,false,{"inclusion":117,"exclusion":130,"raw_text":135},[118,119,120,121,122,123,124,125,126,127,128,129],"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\u002Fdeclination 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.",[131,132,133,134],"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\u002Fneck region that would result in overlap of RT fields.","3.2.3 Patients who have had prior major surgery to the head\u002Fneck 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\u002Fsocial 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","Inclusion Criteria:\n\n* 3.1.1 Patients must have a histologically confirmed HPV-related OPSCC, confirmed by HPV insitu hybridization.\n* 3.1.2 Patients must not have received prior treatment (i.e., no induction chemotherapy).\n* 3.1.3 Patients must have evaluable disease (per RECIST v1.1 response criteria). See Section 6.\n* 3.3 for the evaluation of measurable disease.\n* 3.1.4 Patients must be age ≥ 18 years.\n* 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).\n* 3.1.6 Patient must receive a staging PET scan prior to registration on study.\n* 3.1.7 Patients must exhibit an ECOG performance status of 0-1. Please refer to Appendix A ECOG Performance Status Scale.\n* 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.\n* 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)\n* 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\u002Fdeclination 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.\n* 3.1.11 Patients must have the ability to understand and the willingness to sign a written informed consent document prior to registration.\n\nExclusion Criteria:\n\n* 3.2.1 Patients with cT4, cN3, or cM1 disease by AJCC 8 th edition.\n* 3.2.2 Patients who have had prior RT to the head\u002Fneck region that would result in overlap of RT fields.\n* 3.2.3 Patients who have had prior major surgery to the head\u002Fneck region that could disrupt lymphatic flow as determined by the PI.\n* 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\u002Fsocial 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",[137,138],"ADULT","OLDER_ADULT",[140,156],{"facility":13,"status":8,"city":141,"state":142,"zip":143,"country":144,"contacts":145,"geoPoint":153},"Chicago","Illinois","60611","United States",[146,151],{"name":147,"role":148,"phone":149,"email":150},"Laila A. Gharzai","CONTACT","312-694-6835","laila.gharzai@northwestern.edu",{"name":147,"role":152},"PRINCIPAL_INVESTIGATOR",{"lat":154,"lon":155},41.85003,-87.65005,{"facility":157,"status":8,"city":158,"state":142,"zip":159,"country":144,"contacts":160,"geoPoint":164},"Northwestern Medicine Warrenville","Warrenville","60555",[161],{"name":162,"role":148,"phone":149,"email":163},"Laila Gharzai, MD","cancer@northwestern.edu",{"lat":165,"lon":166},41.81781,-88.1734,[168],{"name":169,"role":148,"phone":170,"email":163},"Study Coordinator","312-695-1301",[172],{"name":173,"affiliation":13,"role":152},"Laila A Gharzai",[],[],{"nct_id":4,"conditions":177,"biomarkers":179},[178],"Oropharyngeal Carcinoma",[180,181],"CDKN2A wt Allele","HPV",{"nct_id":4,"found":15,"summary":183,"prompt_version":193},{"design":184,"status":185,"heading":186,"summary":187,"follow_up":188,"word_count":189,"commitments":190,"compensation":191,"drugs_mentioned":192},"This is an interventional study planning to enroll 100 participants. The phase of the study is not specified.","completed","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.","After treatment, you would be followed up every 3 months for 2 years.",119,"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.","Not stated in the trial record.",[71],"v2"]