Comparative study of two different induction chemotherapy regimens in head and neck cancer
- Conditions
- ocally advanced head and neck cancerCancerMalignant neoplasm of other and ill-defined sites
- Registration Number
- ISRCTN08658578
- Lead Sponsor
- Shahid Beheshti University of Medical Sciences (Iran)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 50
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response will be evaluated at day 21 of second cycle using Response Evaluation Criteria in Solid Tumours (RECIST) criteria and computed topography (CT).
- Secondary Outcome Measures
Name Time Method 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.