Phase II Study of De-intensification of Radiation and Chemotherapy for Low-Risk HPV-related Oropharyngeal Squamous Cell Carcinoma
The aim is to evaluate the pathological response rate of HPV positive and/or p16 positive
low-risk oropharyngeal squamous cell carcinoma (OPSCC) after de-intensified
chemoradiotherapy (CRT). Patients will receive 54 to 60 Gy of Intensity Modulated
Radiotherapy (IMRT) with concurrent weekly intravenous cisplatin (30 mg/m2). Diagnostic
imaging (CT and/or MRI) will be obtained 4 to 8 weeks after completion of CRT to assess
response. All patients will have surgical resection of any clinically apparent residual
primary tumor or biopsy of the primary site if there is no evidence of residual tumor and
will undergo a limited neck dissection to encompass at least those nodal level(s) that were
positive pre-treatment, 4 to 14 weeks after CRT. The primary endpoint of this study is the
rate of pathological complete response (pCR) after CRT. Longitudinal assessments of quality
of life and patient reported outcomes will be obtained prior to, during, and after CRT.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Complete pathological response rate after de-escalated CRT in HPV-positive and/or p16 positive OPSCC.
6 to 14 weeks after the last patient is enrolled, or approximately 24 to 32 months after study being opened
No
Bhishamjit Chera, MD
Principal Investigator
University of North Carolina, Chapel Hill
United States: Institutional Review Board
LCCC1120
NCT01530997
November 2011
January 2016
Name | Location |
---|---|
Rex Healthcare | Raleigh, North Carolina 27607 |
University of Florida, Department of Radiation Oncology | Gainesville, Florida 32610-0385 |
University of North Carolina at Chapel Hill, Department of Radiation Oncology | Chapel Hill, North Carolina 27599 |
Rex Cancer Center of Wakefield | Raleigh, North Carolina 27614 |