Study of Combination Docetaxel and Radiotherapy With or Without Cisplatin to Treat Local Advanced Head and Neck Cancer

NCT ID: NCT00521521

Last Updated: 2009-12-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-07-31

Brief Summary

To evaluate the efficacy of the concomitant combination of radiotherapy and docetaxel with or without cisplatin in terms of objective response rates (WHO criteria).

Conditions

Head and Neck Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

docetaxel and cisplatin

Group Type: ACTIVE_COMPARATOR

docetaxel and cisplatin

Intervention Type: DRUG

docetaxel

Group Type: EXPERIMENTAL

docetaxel

Intervention Type: DRUG

Interventions

docetaxel and cisplatin

Intervention Type: DRUG

docetaxel

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients with locally advanced head and neck cancer (T3 and T4 tumors), epidermoid, histologically proven without metastasis; the primitive site of which is the oral cavity, the oropharynx, the hypopharynx or the larynx.
• Locally advanced tumors which are inoperable, or operable but the patient refuses surgery.
• Age ≥ 18 years and ≤ 70 years.
• PS < 2.
• Satisfactory hematological, hepatic and renal functions: (PN ≥ 2000/mm3, platelet count ≥ 100,000/mm3, hemoglobin ≥ 10g/dl, serum creatinine ≤ 120 µmol/l or creatinine clearance ≥ 60 ml/mn, normal total bilirubin, AST (SGOT) and ALT (SGPT) ≤ 2.5 x the upper limit of normal (ULN) of each center, PAL ≤ 5 x LNS; patients with AST or ALT > 1.5 x LNS combined with PAL > 2.5 x LNS will not be eligible for this trial.

Exclusion Criteria

• Any metastases (other than cervical ganglia).
• Cancer of the cavum and the facial structure.
• Any previous chemotherapy or radiotherapy, irrespective of the reason.
• Any surgery for epidermoid carcinoma in the upper aerodigestive tracts.
• Weight loss ≥10% of total body weight during the last 3 months.
• Any other previous cancer excepting in situ or cutaneous cervical cancer (spinocellular or basocellular).
• Pregnant or nursing women; women of childbearing potential must use an appropriate method of contraception.
• Poorly controlled progressive infection.
• Peripheral neuropathy with NCI grade ≥ 2.
• Neurological or psychiatric disease (dementia, seizures, etc.) that is not compatible with good understanding and sufficient compliance with treatment.
• Any other poorly controlled progressive disease, such as heart failure, symptomatic cardiac rhythm disorders, progressive angina pectoris, or respiratory impairment.
• Any other concomitant investigational treatment.
• Any other concomitant anticancer treatment.
• Allergy to polysorbate 80.
• Definitive formal contraindication to corticosteroids.

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

sanofi-aventis

Principal Investigators

Marie SEBILLE, Dr.

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis

Paris, , France

Countries

France

Other Identifiers

TAX_FR1_236

Identifier Type: -

Identifier Source: org_study_id