Selective Avoidance of Nodal VolumEs at Minimal Risk (GCC 20110)

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

52

Participants

Timeline

Start Date

March 1, 2021

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2027

Conditions
Head and Neck CancerOropharynx CancerOropharyngeal Squamous Cell Carcinoma
Interventions
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.

Trial Locations (6)

21014

Upper Chesapeake Health, Bel Air

21044

Central Maryland Radiation Oncology, Columbia

21061

Baltimore Washington Medical Center, Glen Burnie

21201

Maryland Proton Treatment Center, Baltimore

UMMC, Baltimore

University of Maryland Greenebaum Cancer Center, Baltimore

All Listed Sponsors
lead

University of Maryland, Baltimore

OTHER