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Number: 201207059 Principal Investigator: Haughey, Bruce
Title: Adjuvant De-escalation, Extracapsular Spread, P16+, Transoral (A.D.E.P.T) Trial for Oropharhynx Malignancy
Phase: III Disease Site: Lip, Oral Cavity and Pharynx
Participating Site(s):
 
Main Campus
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South County
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West County
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Contact: 800-600-3606 or info@ccadmin.wustl.edu

Description:
This research study is looking at cancer of
the oropharynx (tonsil and/or base of the tongue) which has been shown to be related to the human papillomavirus (HPV) and which has lymph nodes showing extracapsular spread, meaning that the cancer in the lymph nodes is exposed to the soft tissue around the lymph node. Head and neck cancers with extracapsular spread are more likely to be treated with surgery followed by radiation therapy and chemotherapy together. This practice is based on studies of patients with a wide range of head and neck cancers (not just HPV-related oropharynx cancers) that demonstrated
extracapsular spread along with other high risk factors. In these studies, patients with oropharynx cancer were a minority of the participants in the study and, importantly, it was unknown whether the cancers were related to HPV. However, it is probable there were some HPV-related oropharyngeal cancer
patients in this study, raising the consequent possibility that there was a significant difference in recurrences of cancer, in favor of adding chemotherapy to the postoperative treatment program. However, our preliminary data in studies that are restricted to patients with your type of oropharynx
cancer indicate that, controlling for known influential factors, the addition of chemotherapy did not significantly impact disease recurrence or survival.
 
More Information:
ClinicalTrials.gov Entry
Internal Protocol Documents (requires Siteman administrative database password)