Locally advanced head and neck cancer Cancer Malignant neoplasm of other and ill-defined sites
Conditions
Interventions
Eligible patients will be randomised to receive CF or DCF.
Patients in CF arm will receive cisplatine 75 mg/m2 on day 1 and 5Fu 750 mg/m2 on day 1 to 5 of each cycle.
Patients in DCF group will recei
Sponsors
Shahid Beheshti University of Medical Sciences (Iran)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histological proven head and neck squamous cell carcinoma other than salivary gland tumour and sinonasal carcinoma 2. Measurable primary tumour or lymph node or both 3. T3 or T4 N0, T1-T4 N2-3 4. Age from 16 till 70 years 5. Performance status =2 according to ECOG classification 6. No previous chemotherapy is allowed 7. Adequate bone marrow, hepatic & renal functions 7.1. Haemoglobin = 11 g/dl, 7.2. Platelets = 100000 / mm3 7.3. Absolute Neutrophil Count = 1500/mm3 7.4. Bilirubin = Normal Value 7.5. Transaminases = Normal Value 7.6. Creatinine = 1 mg/dl 8. Absence of neuropathy 9. Absence of active co-morbid illness (uncontrolled infection, cardiopulmonary disease?) 10. Complete initial work up within 2 weeks prior to first chemotherapy infusion
Exclusion criteria
Exclusion criteria: 1. Any metastasis 2. Pregnant or lactating women. 3. Other serious illness or medical conditions. 4. Any chemotherapy administered before entering study 5. Any patient with early stage cancer who can be treated without mutilating surgery 6. Any contraindication for one of the drugs in chemotherapeutic regimens or radiotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response will be evaluated at day 21 of second cycle using Response Evaluation Criteria in Solid Tumours (RECIST) criteria and computed topography (CT). | — |
Secondary
| Measure | Time frame |
|---|---|
| Toxicity will be evaluated at day 21 of each cycle and the most serious adverse effect according to WHO criteria during the cycle will be recorded. | — |
Countries
Iran
Outcome results
None listed