Clinical Studies Search

Protocol Summary


Protocol No.
PSCI-20-011
Prinicipal Investigator
Almokadem, Salah
Phase
Phase II/III
Age Group
Adult
Scope
National
Secondary Protocol No.
NRG-HN005
Title
NRG-HN005 - A Randomized Phase II/III Trial of De-intensified Radiation Therapy for Patients with Early-Stage, P16-Positive, Non-Smoking Associated Oropharyngeal Cancer
Objective
Phase II: To demonstrate non-inferiority in terms of progression-free survival (PFS) of concurrent reduced-dose radiation therapy (RT) with cisplatin or concurrent reduced-dose radiation therapy with nivolumab to the current standard of care (standard-dose RT with cisplatin).

Phase III: To demonstrate co-primary endpoints of non-inferiority of PFS and superiority of quality of life (QOL) as measured by the MDADI of concurrent reduced-dose radiation with cisplatin or concurrent reduced-dose radiation with nivolumab to the current standard of care (standard-dose RT with cisplatin).
Applicable Disease Sites
Head and Neck
Status
Open
Participating Institutions
Hershey Medical Center