Clinical trial NCT01221753: Docetaxel/Cisplatin/5-Fluorouracil (TPF) Human Papillomavirus (HPV) Squamous Cell Carcinoma Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Squamous Cell Carcinoma of the Head and Neck
Human Papilloma Virus
Keywords: SSCHN
HPV
IMRT
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2010-10-15
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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

Eligibility criteria: 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

Primary outcomes:
measure: 2-Year Local-Regional Control Rate
timeFrame: Follow-up for response continued until first progression. Disease assessments occurred at completion of induction cycle 3 along with months 12, 18 and 24 post study registration.
Secondary outcomes:
measure: 4-y Overall Survival Rate
timeFrame: Patients were followed for survival up to 5 years from study entry. Patients alive have been followed for a mean of 55 months (range 52-60 months).
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Robert Haddad, MD
role: PRINCIPAL_INVESTIGATOR
References: