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
Northwestern University
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. 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.
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 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). V. 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). OUTL…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 ex…
Interventions
- ProcedureComputed Tomography
Undergo CT
- ProcedureNasopharyngeal Laryngoscopy
Undergo nasopharyngolaryngoscopy
- ProcedurePositron Emission Tomography
Undergo PET
- OtherQuestionnaire Administration
Ancillary studies
- RadiationRadiation Therapy
Undergo radiation therapy
Location
- Northwestern UniversityChicago, Illinois