Clinical trial NCT00521521: Study of Combination Docetaxel and Radiotherapy With or Without Cisplatin to Treat Local Advanced Head and Neck Cancer
Official title: A Multicenter, Randomized, Phase II Study of the Combination of Docetaxel (TAXOTERE) and Concomitant Radiotherapy With or Without Cisplatin in Patients With Locally Advanced Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Head and Neck Neoplasms
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-08-28
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Objective response rates
timeFrame: evaluated 8 weeks after the end of radiotherapy
Secondary outcomes:
measure: Duration of the responses and overall survival
timeFrame: time until progression
Other outcomes:
Locations:
city: Paris
country: France
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: Marie SEBILLE, Dr.
role: STUDY_DIRECTOR
References: