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)

Head and Neck Neoplasms Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00357149
• Other study ID #: XRP6976F_2501
• Status: Completed
• Phase: Phase 2
• First received: July 26, 2006
• Last updated: December 4, 2009
• Start date: January 2003

Study information

• Verified date: December 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Head and Neck Neoplasms

Intervention

Drug:
• Docetaxel, cisplatin and 5-FU treatment followed by concomitant cisplatin, 5-FU and radiotherapy

• Concomitant cisplatin, 5-FU and radiotherapy

Locations

Country	Name	City	State
Italy	Sanofi-Aventis	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of radiologic Complete Response (CR) evaluated 6-8 weeks after the completion of treatment		from end of treatment until 6-8 weeks	No
Secondary	Duration of response		from the date of first documented tumor response to the date of first documented tumor progression	No
Secondary	Time to disease progression		From the date of the treatment start to the date of first documented progression of disease	No
Secondary	Time to treatment failure		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	No
Secondary	Median length of overall survival		time interval from the date of treatment to the date of death	No