Neoadjuvant Docetaxel Plus Cisplatin and 5-Fluorouracil (TPF) Followed by Concomitant Chemoradiotherapy and Chemoradiotherapy Alone in Locally Advanced 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 6-8 weeks 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 and 5-FU treatment followed by concomitant cisplatin, 5-FU and radiotherapy Drug: Concomitant cisplatin, 5-FU and radiotherapy	Phase II

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.

Resource links provided by NLM:

MedlinePlus related topics: Cancer Head and Neck Cancer Radiation Therapy

Drug Information available for: Fluorouracil Cisplatin Docetaxel

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Rate of radiologic Complete Response (CR) evaluated 6-8 weeks after the completion of treatment [ Time Frame: from end of treatment until 6-8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Duration of response [ Time Frame: from the date of first documented tumor response to the date of first documented tumor progression ] [ Designated as safety issue: No ]
Time to disease progression [ Time Frame: From the date of the treatment start to the date of first documented progression of disease ] [ 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 ]
Median length of overall survival [ Time Frame: time interval from the date of treatment to the date of death ] [ Designated as safety issue: No ]

Enrollment:	101
Study Start Date:	January 2003
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator Cisplatin from day 1 to day 4 and 5-FU for 4 days starting immediately after the end of cisplatin infusion on day 1. Both drugs were administered during week 1 and 6 of irradiation, starting from day 1 of weekly radiotherapy.	Drug: Concomitant cisplatin, 5-FU and radiotherapy
B: Experimental Docetaxel followed by cisplatin and 5-FU from day 1 to day 4 starting after the end of cisplatin infusion. The cycle was repeated every 3 weeks up to a total of 3 cycles. After 3-6 weeks from the end of neoadjuvant chemotherapy, patients will receive with the same modality of arm A (reference arm).	Drug: Docetaxel, cisplatin and 5-FU treatment followed by concomitant cisplatin, 5-FU and radiotherapy

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 III or IV disease without evidence of distant metastases verified by chest X Ray and/or lung CT scan, 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

Additional Information:

CSR synopsis This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers:	XRP6976F_2501
Study First Received:	July 26, 2006
Last Updated:	May 20, 2009
ClinicalTrials.gov Identifier:	NCT00357149 History of Changes
Health Authority:	Italy: Ministry of Health

Study placed in the following topic categories:

Antimetabolites
Immunologic Factors
Carcinoma, Squamous Cell of Head and Neck
Squamous Cell Carcinoma
Immunosuppressive Agents
Carcinoma
Docetaxel
Cisplatin

Radiation-Sensitizing Agents
Head and Neck Neoplasms
Fluorouracil
Epidermoid Carcinoma
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Neoplasms by Histologic Type
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions
Carcinoma
Docetaxel

Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Cisplatin
Head and Neck Neoplasms
Fluorouracil
Therapeutic Uses
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 10, 2009