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Selective Avoidance of Nodal VolumEs at Minimal Risk (GCC 20110)
Sponsor: University of Maryland, Baltimore
Summary
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.
Official title: A Single-arm, Single-stage Phase II Trial of Selective Avoidance of Nodal VolumEs at Minimal Risk (SAVER) in the Contralateral Neck of Patients With p16-positive Oropharynx Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
52
Start Date
2021-03-01
Completion Date
2027-12
Last Updated
2025-07-29
Healthy Volunteers
No
Interventions
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.
Locations (6)
Maryland Proton Treatment Center
Baltimore, Maryland, United States
UMMC
Baltimore, Maryland, United States
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, United States
Upper Chesapeake Health
Bel Air, Maryland, United States
Central Maryland Radiation Oncology
Columbia, Maryland, United States
Baltimore Washington Medical Center
Glen Burnie, Maryland, United States