Reduced-intensity Therapy for Advanced Oropharyngeal Cancer in Non-smoking Human Papilloma Virus (HPV)-16 Positive Patients
Status: | Completed |
---|---|
Conditions: | Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | Any |
Updated: | 11/18/2012 |
Start Date: | June 2010 |
End Date: | January 2016 |
Contact: | Avraham Eisbruch, MD |
Email: | eisbruch@umich.edu |
Phone: | (734) 936-4300 |
The study aim is to assess whether reducing treatment intensity by replacing concurrent
chemotherapy with cetuximab, will indeed achieve improved long-term toxicity. This aim will
be tested in a prospective study in which acute and long-term sequelae will be graded by
observers (using Common Terminology Criteria for Adverse Events (CTCAE) v3 scales), and by
patients, Dysphagia will also be assessed objectively by videofluoroscopy.
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.
Inclusion Criteria:
- pathologically-confirmed, previously untreated, stage IIIIV(excluding N3) squamous
cell carcinoma of the oropharynx, without evidence of distant metastasis
- Pretreatment tumor biopsy with sufficient tumor for HPV analysis is required. The
tumor must be HPV(+)/p16(+)
- Never smokers (including cigarettes, cigars, pipes, chewing tobacco, and/or
marijuana)
- Karnofsky Performance Status (KPS) > 80
- pre-treatment endoscopic tumor staging and PET-CT scanning
- appropriate lab levels and creatinine clearance
Exclusion Criteria:
- Prior head and neck malignancy or history of other prior non-head and neck malignancy
(excluding skin cancer and early stage treated prostate cancer) within the past 3
years
- Prior head and neck radiation or chemotherapy
- Any medical or psychiatric illness, which in the opinion of the principal
investigator,would compromise the patient's ability to tolerate this treatment or
limit compliance with study requirements
- prisoners
- Patients with prior anti-epidermal growth-factor receptor antibody therapy (antibody
or small molecule)
We found this trial at
1
site
1500 East Medical Center Drive
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
800-865-1125
![University of Michigan Comprehensive Cancer Center](/wp-content/uploads/logos/university-of-michigan-comprehensive-cancer-center.jpg)
University of Michigan Comprehensive Cancer Center The U-M Comprehensive Cancer Center's mission is the conquest...
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)