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ACTIVE NOT RECRUITING
NCT04609280
PHASE2

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

Sponsor: University of Maryland, Baltimore

View on ClinicalTrials.gov

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

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.

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