NCT01221753

Docetaxel/Cisplatin/5-Fluorouracil (TPF) Human Papillomavirus (HPV) Squamous Cell Carcinoma Study

A Phase II Study of Docetaxel/Cisplatin/5-Fluorouracil (TPF) Induction Chemotherapy Followed by Concurrent Chemoradiotherapy Using a Modified Radiation Dose in Patients With Newly Diagnosed HPV Positive, Locally Advanced Squamous Cell Carcinoma of the Oropharynx

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this research study, the investigators are studying whether a reduced dose of radiation when given with standard doses of chemotherapy can reduce side effects without compromising control of the cancer. An approved treatment for squamous cell carcinoma of the head and neck is initial chemotherapy followed by radiation and chemotherapy together. This treatment is effective but has many immediate and long-term side effects. People who have squamous cell carcinoma of the head and neck (SSCHN) that is related to an infection by the human papillomavirus (HPV) have been shown to have a high response to this treatment along with a high cure rate. The investigators think that by reducing the intensity of this treatment, they may be able to reduce immediate and long-term side effects which may lead to long term improvements in quality of life and function.

Detailed description

OBJECTIVES: Primary To determine rate of local-regional control at 2 years Secondary To determine Progression Free Survival at 2 and 5 years To determine Overall Survival at 2 and 5 years To assess acute toxicity and long term toxicity of reduced radiation dose at 2 and 5 years

Conditions

• Squamous Cell Carcinoma of the Head and Neck
• Human Papilloma Virus

Interventions

Type	Name	Description
DRUG	docetaxel
DRUG	cisplatin	Given intravenously on day 1 of each cycle
DRUG	5-FU
RADIATION	IMRT
DRUG	cetuximab
DRUG	carboplatin

Timeline

• Start date: 2011-07-01
• Primary completion: 2012-07-01
• Completion: 2017-07-01
• First posted: 2010-10-15
• Last updated: 2017-12-06
• Results posted: 2016-12-06

Locations

1 site across 1 country: United States