Neoadjuvant Docetaxel Plus Cisplatin and 5-Fluorouracil (TPF) Followed by Concomitant Chemoradiotherapy and Chemoradiotherapy Alone in Squamous Cell Carcinoma of the Head and Neck Patients (SCCHNS) - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00357149

Purpose

to evaluate the rate of clinical complete response after treatment with docetaxel plus cisplatin and 5-fluorouracil followed by chemoradiotherapy and after chemoradiotherapy alone in patients with locally advanced squamous cell carcinoma of the head and neck.

Condition	Intervention	Phase
Head and Neck Neoplasms	Drug: Docetaxel, cisplatin, 5-FU Drug: Cisplatin, 5-FU	Phase II

MedlinePlus related topics: Cancer Head and Neck Cancer

Drug Information available for: Docetaxel Cisplatin Fluorouracil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Randomized Phase II Trial of Neoadjuvant Docetaxel Plus Cisplatin and 5-Fluorouracil Followed by Concomitant Chemoradiotherapy and Chemoradiotherapy Alone in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck.

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Tumor response will be evaluated according to RECIST criteria. [ Time Frame: prior to treatment start until progression of disease ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

duration of objective response [ Time Frame: from the date of first documented response to the date of first documented tumor progression. ] [ Designated as safety issue: No ]
Time to progression [ Time Frame: from the date of treatment start to the date of the first documented tumor progression or relapse ] [ Designated as safety issue: No ]
Time to treatment failure [ Time Frame: from the date of treatment start to the date of diagnosis of progression, withdrawal from study treatment for any reason, administration of other antitumor treatment, or death for any cause ] [ Designated as safety issue: No ]
overall survival [ Time Frame: time interval from the date of treatment start to the date of death ] [ Designated as safety issue: No ]
Adverse events/signs [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	96
Study Start Date:	January 2003
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator	Drug: Cisplatin, 5-FU concomitant chemotherapy
B: Experimental	Drug: Docetaxel, cisplatin, 5-FU TPF neoadjuvant treatment followed by chemotherapy

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Histologically or cytologically proven squamous cell carcinoma of the head and neck.
Primary tumor sites eligible: oral cavity, oropharynx, hypopharynx. Although they are admittedly of squamous cell types, the following tumors will be excluded because of theY responsiveness to chemotherapy: tumors of the nasal and paranasal cavities, larynx and of the nasopharynx.
Stage 3 or 4 disease without evidence of distant metastases verified by chest X Ray, abdominal ultrasound, or CT (liver function test abnormalities); bone scan in case of local symptoms.
At least one measurable lesion.
Tumor considered inoperable after evaluation by a multidisciplinary team (i.e. a surgeon, a medical oncologist and a radiation oncologist).
No previous chemotherapy or radiotherapy for any reason and no previous surgery for squamous cell carcinoma of the head and neck patients (other than biopsy) are allowed at time of study entry.
Karnofsky performance status > 70.
No active alcohol addiction.
Adequate bone marrow, hepatic and renal functions
Patients must be available for treatment and follow-up.

Exclusion criteria

Pregnant or lactating women or women of childbearing potential not using adequate contraception.
Previous or current malignancies at other sites, with the exception of adequately treated in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma of the skin, or other cancer curatively treated by surgery and with no evidence of disease for at least 5 years.
Symptomatic peripheral neuropathy > grade 2
Symptomatic altered hearing > grade 2
Other serious illnesses or medical conditions including:a) Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry.b) History of significant neurologic or psychiatric disorders including dementia or seizures.c) Active uncontrolled infection.d) Active peptic ulcer.e) Hypercalcemia.f) Chronic obstructive pulmonary disease requiring hospitalization during the year preceding study entry
History of hypersensitivity reaction to polysorbate 80
Patients requiring intravenous alimentation.
Patients who experienced a weight loss of more than 20% of their body weight in the 3 months preceding study entry.
Concomitant treatment with any other anticancer therapy.
Participation in a therapeutic clinical trial within 30 days of study entry

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00357149

Locations

Italy
Sanofi-aventis
Milan, Italy

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Georges Paizis, MD

Sanofi-Aventis

More Information

CSR synopsis This link exits the ClinicalTrials.gov site

Responsible Party:	sanofi-aventis ( Medical Affairs Medical Director )
Study ID Numbers:	XRP6976F_2501
Study First Received:	July 26, 2006
Last Updated:	October 7, 2008
ClinicalTrials.gov Identifier:	NCT00357149
Health Authority:	Italy: Ministry of Health

Study placed in the following topic categories:

Docetaxel
Epidermoid carcinoma
Cisplatin
Fluorouracil
Squamous cell carcinoma
Head and Neck Neoplasms

Carcinoma, squamous cell
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Carcinoma, squamous cell of head and neck
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Antimetabolites
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs

Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on January 16, 2009