Health Condition 1: null- Cancer
Conditions
Interventions
Intervention1: Docetaxel,Cisplatin: Patients to receive a 1-hour intravenous infusion of Docetaxel at 75 mg/m2 followed by a 30-
minute intravenous infusion of cisplatin at 75 mg/m2.
Docetaxel and ci
platelet count more than equal to 100,000/ ml) by the start of the next scheduled
chemotherapy cycle.
Intervention2: Docetaxel,Cisplatin: This is an interventional study to assess the overall response
platelet count / 100,000/ ml) by the start of the next scheduled
chemotherapy cycle.
Intervention5: Docetaxel: Patients to receive a 1-
Sponsors
Dr Rangaraju Ranga Rao
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the overall response (OR)rate (including CR & partial response (PR)) of subjects treated with induction regimen Docetaxel and cisplatin followed by the chemoradiotherapy in patients with locally advanced head and neck cancer.Timepoint: Screening, Induction (Day 1/Week 1/Cycle 1, Week 4/Cycle 2, Week 7/Cycle 3), FU post induction (21 days +/- 2 days after day 1/cycle3), CCRT (Week 10, 13, 16), FU (8 weeks post cycle 6) | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety and tolerability of iduction regimen Docetaxel and Cisplatin followed by the Chemoradiotherapy in patients with locally advanced head and neck cancerTimepoint: Screening, Induction (Day 1/Week 1/Cycle 1, Week 4/Cycle 2, Week 7/Cycle 3), FU post induction (21 days +/- 2 days after day 1/cycle3), CCRT (Week 10, 13, 16), FU (8 weeks post cycle 6) | — |
Countries
India
Contacts
Public ContactDr Rangaraju Ranga Rao
Outcome results
None listed