Reduced-intensity Therapy for Advanced Oropharyngeal Cancer in Non-smoking Human Papilloma Virus (HPV)-16 Positive Patients
These measures will be compared to the investigators historical control group (consisting of
non-smoking patients with advanced oropharyngeal cancer who received standard-intensity
chemo-radiation therapy and were evaluated by the same tools on UMCC protocol 2-21, IRB #
2002-513). Strict stopping rules will be enacted to ensure that reducing treatment intensity
does not increase tumor failures compared with the investigators previous results using
standard therapy.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Patients with Tumor Reoccurrence
To confirm that reducing treatment intensity in non-smoking patients with HPV related oropharyngeal cancer by replacing concurrent chemotherapy with concurrent cetuximab, does not significantly increase the proportion of patients whose tumors recur, compared to our previous experience in similar patients receiving chemo-radiation therapy (RT).
6 months
Yes
Avraham Eisbruch, MD
Principal Investigator
University of Michigan Cancer Center
United States: Institutional Review Board
UMCC 2009-078
NCT01649414
June 2010
January 2016
Name | Location |
---|---|
University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |