A Phase 2 interventional study of Intensity modulated radiotherapy (IMRT)/volumetric modulated arc therapy (VMAT) or Pencil beam proton therapy (PBPT) in Head and Neck Cancer, Oropharynx Cancer and Oropharyngeal Squamous Cell Carcinoma, sponsored by University of Maryland, Baltimore. Active, not recruiting at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by University of Maryland, Baltimore · Phase 2, Interventional, and Treatment
This is a phase II, non-randomized, therapeutic trial with the primary objective to determine the efficacy of reduced contralateral (C/L) elective nodal treatment volumes in preventing C/L recurrences at 2 years in patients with p16 positive oropharyngeal squamous cell carcinoma undergoing definitive or adjuvant RT.
Patients with human papillomavirus (HPV) or its surrogate marker p16, positive oropharyngeal squamous cell carcinoma (p16+OPSCC) exhibit favorable overall survival (OS) rates of 70-100% at 3 years. These outcomes are dependent on disease burden and patient characteristics and independent of treatment modality. Significant treatment related side effects exist despite advances in radiotherapy (RT) technology, surgical techniques, and supportive care. In addition to common acute toxicities, the favorable OS of patients with p16+OPSCC potentially places them at increased risk for developing long-term treatment-induced side-effects. Therefore, it is important to establish novel management approaches that maintain excellent current clinical outcomes while effectively reducing acute and long-term side effects.
One such approach of limiting RT-induced toxicity is to decrease the amount of normal tissue that receives radiation through judicious reduction of RT treatment volumes. Treatment of elective nodal volumes increases dose to numerous organs at risk (OARs). Patients with well-lateralized tonsil tumors and limited neck disease can effectively be treated with ipsilateral nodal radiotherapy. However, based on recent phase III trials, contralateral (C/L) elective nodal radiation is performed for the majority of patients with p16+OPSCC increasing acute and long-term toxicities. Therefore, judicious data-driven approaches for decreasing the number of elective ipsilateral and contralateral nodal levels treated is necessary to limit RT-induced side effects. This protocol tests the hypothesis that treating only the high-risk sub-volumes of levels II and III would be effective in maintaining regional control in the elective neck while decreasing xerostomia (dry mouth) and dysphagia (swallowing difficulties).
2,344 studies on the registry are indexed under Head and Neck Neoplasms; 552 are open to participants now.
This study's enrollment of 52 is above the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →University of Maryland, Baltimore is the lead sponsor of 687 studies on the registry; 130 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 63 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All patients will receive the reduced C/L elective nodal volume as described. Treatment will be delivered via IMRT/VMAT or PBPT.
Radiation: Intensity modulated radiotherapy (IMRT)/volumetric modulated arc therapy (VMAT) or Pencil beam proton therapy (PBPT)
Delivered over 6 weeks in 30 daily fractions in the adjuvant setting and over 6.5 weeks in 33 daily fractions in the definitive setting. In the adjuvant setting, areas with positive surgical margins or nodal stations with pathologic extranodal extension will receive 63 Gy. Margin negative resection bed and involved nodal stations without extranodal extension will receive 54 Gy. Low-risk elective nodal volumes (i.e. ceCTV) will receive 51 Gy. In the definitive setting, gross disease will receive 69.96 Gy, areas at high-risk for subclinical disease will receive 60 Gy, and areas at low-risk for harboring subclinical disease (i.e. ceCTV) will receive 52.8 Gy.
Elective out-of-field contralateral nodal failure
Time to failure will be calculated from the date of informed consent until the date of nodal failure in the untreated elective neck sub-volume.
Time frame: 2-years following completion of radiotherapy
Grade 2/3 xerostomia
defined by PRO-CTCAE (patient-reported outcome (PRO) measurement system - Common Terminology Criteria for Adverse Events (CTCAE))
Time frame: 2-years following completion of radiotherapy
Dysphagia using The M.D. Anderson Dysphagia Inventory (MDADI)
The M.D. Anderson Dysphagia Inventory is a self-administered questionnaire designed specifically for evaluating the impact of dysphagia on the Quality of Life (QOL) of patients with head and neck cancer.
Time frame: 2-years following completion of radiotherapy
PEG-tube rate
Percutaneous endoscopic gastrostomy (PEG)-tube rate
Time frame: 2-years following completion of radiotherapy
Overall survival
Time frame: 2-years following completion of radiotherapy
Progression-free survival
Time frame: 2-years following completion of radiotherapy
Locoregional control
Time frame: 2-years following completion of radiotherapy
Incidence of pulmonary metastases
Time frame: 2-years following completion of radiotherapy
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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University of Maryland, Baltimore