drugset / Trial / NCT01525927

Study of Chemotherapy Prior to Radiotherapy and Chemotherapy in Patients With HPV Associated Cancer of the Oral Cavity

Phase 2 Terminated 2 enrolled Northwell Health

Non-randomizedSingle-groupOpen-labelTreatment

Summary

This study looks at the use of three cycles of chemotherapy given prior to radiation therapy in patients with cancer of the oral cavity and evidence of prior exposure to Human Papilloma Virus (HPV). Patients with cancer of the oral cavity who have evidence of exposure to HPV have a better prognosis than those who do not have such evidence of exposure to HPV. The main hypothesis of this study is that using three cycles of chemotherapy prior to embarking on radiation therapy will allow the use of reduced doses of radiation therapy and, therefore, less radiation induced side-effects. The primary objective is to determine the activity of this pre-radiation chemotherapy strategy along with reduced dose levels of radiation with or without chemotherapy during the radiation phase. The effectiveness of the strategy will be assessed at three months following the completion of the radiation therapy phase and also at two years following completion of the radiation therapy.

Timeline

Start: 2010-08
Primary completion: 2011-12
Completion: 2011-12

Outcome

Outcome not reported

Stopped: “Principal Investigator left institution. IRB approval lapsed.”

Publications

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Carboplatin	Small molecule	1.5 unknown	—
Subject	Cisplatin	Other / unclassified	35 mg/m2	Intravenous
Subject	Cisplatin	Other / unclassified	75 mg/m2	Intravenous
Subject	Etoposide	Small molecule	—	—
Subject	fluorouracil	Small molecule	750 mg/m2	Intravenous