To evaluate the overall improvement of subjects treated with Docetaxel and Cisplatin in patients with locally advanced head and neck cancer

Phase 4

Completed

Conditions: Health Condition 1: null- Cancer

Registration Number: CTRI/2011/06/001775

Lead Sponsor: Dr Rangaraju Ranga Rao

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

1. Histologically confirmed, unresectable locally advanced SCCHN of oral cavity,oropharynx, larynx or hypopharynx in stage 3 to 4 without evidence of distant metastases

2. No prior chemotherapy or radiation therapy

3. Having at least one measurable lesion in one dimension

4. Age more than or equal to 18 and less than 65 years with Eastern Cooperative Oncology Group less than or equal to 1

5. Adequate haematological function with neutrophil count P 1500 per ml and platelets more than equal to 100000 per ml and haemoglobin more than equal to 10 gram per ml

6. Adequate hepatic function with bilirubin less than or equal to 1 multiplied by the upper normal limit, GOT and GPT 62.5 multiplied by the upper normal limit and alkaline phosphatase 65 multiplied by the upper normal limit

7. Renal function within normality with serum creatinine less than equal to 1.4 mg per dl and creatinine clearance more than equal to 60 ml per min calculated by the Cockcroft?Gault method.

Exclusion Criteria

1. Peripheral neuropathy or other serious diseases like unstable ischaemic heart disease, acute myocardial infarction 6 months prior to inclusion, history of significant neurological or

psychiatric disorder or active peptic ulcer

2. Being treated concomitantly with corticosteroids except as premedication

3. Patients having another type of neoplasm.

4. Previous chemotherapy or radiotherapy

5. Any previous definitive surgery for squamous cell carcinoma of head and neck

6. Severe weight loss 20 percent of body weight in the preceding 3 months