Status:
TERMINATED
Docetaxel/Cisplatin/5-Fluorouracil (TPF) Human Papillomavirus (HPV) Squamous Cell Carcinoma Study
Lead Sponsor:
Dana-Farber Cancer Institute
Conditions:
Squamous Cell Carcinoma of the Head and Neck
Human Papilloma Virus
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ca...
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 ass...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Histologically or cytologically confirmed squamous cell carcinoma of the oropharynx or unknown primary that is HPV 16 positive as determined by ISH and p16 positive as determined by IHC.
- Stage 3 or 4 disease without evidence of distant metastases
- At least one evaluable or uni- or bi-dimensionally measurable lesion by RECIST 1.1 criteria
- 18 years of age or older
- No previous surgery, radiation therapy or chemotherapy for SSCHN is allowed at time of study entry
- ECOG Performance Status of 0 or 1
- No active alcohol addiction
- Adequate bone marrow, hepatic and renal function as defined in the protocol
- Women of child-bearing potential must have a negative pregnancy test within 7 days of starting treatment
- Exclusion Criteria
- Pregnant or breast feeding women or women and men of childbearing potential not willing to use adequate contraception while on treatment and for at least 3 months after
- Previous or current malignancies at other sites
- Symptomatic peripheral neuropathy of grade 2 or greater
- Symptomatic altered hearing greater than grade 2
- Other serious illnesses or medical conditions
- Patients that have experienced an involuntary weight loss of more than 25% of their body weight in the 2 months preceding study entry
- Concurrent treatment with any other anticancer therapy
- Participation in an investigational trial within 30 days of study entry
Exclusion
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2017
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT01221753
Start Date
July 1 2011
End Date
July 1 2017
Last Update
December 6 2017
Active Locations (1)
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1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115