Resumen

* 1. Comparar la supervivencia global después del tratamiento con la triterapia experimental (TPF: docetaxel más cisplatino y 5FU) o el tratamiento control (PF: cisplatino más 5-FU) seguido de quimiorradioterapia en pacientes con carcinoma de células escamosas de cabeza y cuello localmente avanzado. * 2. El criterio de valoración secundario principal es la supervivencia libre de progresión (SLP). Los otros criterios de valoración secundarios son evaluar y comparar la mejoría de los síntomas locales; el tiempo hasta el fracaso del tratamiento; la calidad de vida; la tasa de respuesta clínica completa (RC y RC/RP); la toxicidad y evaluar la relación entre los marcadores tumorales y la respuesta al tratamiento.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Histologically or cytologically proven squamous cell carcinoma of the head/neck.
Primary tumor sites eligible: oral cavity, oropharynx, hypopharynx, larynx. Although they are admittedly of squamous cell types, the following tumors will be excluded because their responsiveness to chemotherapy may differ: nasal, paranasal cavities; nasopharynx.
Stage 3 or 4 disease without evidence of distant metastases verified with Chest X-Ray, abdominal ultrasound or CT (liver function test abnormalities); bone scan in case of local symptoms.
At least one uni or bidimensionally measurable lesion.
Tumor considered as inoperable after evaluation by a multidisciplinary team (surgeon, medical oncologist and radiation oncologist). Criteria include : Technical unresectablility-ie tumor fixation/invasion to base of the skull or cervical vertebrae involvement of the nasopharynx and fixed lymph nodes; Physician's decision based on low surgical curability which includes all T3-4 stages, all N2-3 stages excluding T1N2; organ preservation.
No previous chemotherapy or radiotherapy for any reason and no previous surgery for SCCHN (other than biopsy) are allowed at time of study entry.
Age ³ 18 years.
WHO performance status of 0-1
No active alcohol addiction
Life expectancy ³ 12 weeks
Signed informed consent prior to beginning protocol specific procedures
Adequate bone marrow, hepatic and renal functions as evidenced by the following: Hematology (Bone Marrow): Neutrophil count ³ 2.0 x 10 9/L; Platelet count ³ 100 X 10 9/L; Hemoglobin ³ 10g/dL; Hepatic function : Total bilirubin WNL; ASAT (SGOT) and ALAT (SGPT) £ 2.5 X ULN; Alkaline phosphatase £ 5 X ULN; patients with ASAT or ALAT \> 1.5 x ULN associated with alkaline phosphatase \> 2.5 x ULN are not eligible for the study; Renal function: the creatinine clearance ³ 60 ml/min (actual or calculated by the Cockcroft-Gault method as follows: Weight (kg) X (140-age)/K x serum creatinine.
Patients must be available for treatment and follow up. Patients registered on this trial must be treated and followed at the participating center.

Criterios de exclusión

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. Any prior treatment with radiotherapy or chemotherapy is an exclusion criterion.
Symptomatic peripheral neuropathy ³ grade 2 by NCIC-CTG criteria.
Symptomatic altered hearing \> grade 2 by NCIC-CTG criteria.
Other serious illnesses or medical conditions including but no limited to: Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry; History of significant neurologic or psychiatric disorders including dementia or seizures; Active uncontrolled infection; Active peptic ulcer; Hypercalcemia; Chronic obstructive pulmonary disease requiring hospitalization during the year preceding study entry.
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.
Concurrent treatment with any other anticancer therapy
Participation in an investigational trial within 30 days of study entry.

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

XRP6976 (Docetaxel/Taxotere)

Ubicaciones

Sanofi-Aventis Administrative Office

Patrocinadores