To study response rate after chemotherapy in inoperable of head and neck cancers.
- Conditions
- Health Condition 1: null- Patients with histologically confirmed, unresectable locally advanced SCCHN of oral cavity, oropharynx, larynx or hypopharynx in stage IIIâ??IV without evidence of distant metastases
- Registration Number
- CTRI/2015/08/006080
- Lead Sponsor
- Aventis Pharma Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
(i)histologically confirmed, unresectable locally advanced SCCHN of oral cavity, oropharynx, larynx or hypopharynx in stage IIIâ??IV without evidence of distant metastases
(ii)no prior chemotherapy or radiation therapy;
(iii)having at least one measurable lesion in one dimension;
(iv)age >18 & <65 years with Eastern Cooperative Oncology Group (ECOG) < 1;
(v)adequate haematological function with neutrophil count P1500/ml, platelets >100,000/ml and haemoglobin >10 g/ml;
(vi)adequate hepatic function with bilirubin <1• the upper normal limit, GOT and GPT 62.5 the upper normal limit and alkaline phosphatase 65 5 times the upper normal limitthe upper normal limit;
(vii)renal function within normality with serum creatinine <1.4 mg/dl and creatinine clearance >60 ml/ min calculated by the Cockcroftâ??Gault method.
(i)Peripheral neuropathy or other serious diseases (unstable ischaemic heart disease, acute myocardial infarction 6 months prior to inclusion, history of significant neurological or psychiatric disorder or active peptic ulcer)
(ii)Being treated concomitantly with corticosteroids (except as pre-medication)
(iii)Patients having another type of neoplasm.
(iv)Previous chemotherapy or radiotherapy
(v)Any previous definitive surgery for squamous cell carcinoma of head and neck
(vi)Severe weight loss ( > 20 % of body weight) in the preceding 3 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the overall response (OR) rate (including CR and partial response (PR)) of subjects treated with induction regimen Docetaxel and cisplatin with locally advanced head and neck cancer. <br/ ><br> <br/ ><br>Timepoint: Response after Neoadjuvant Chemotherapy <br/ ><br> <br/ ><br>
- Secondary Outcome Measures
Name Time Method To assess the safety and tolerability of induction regimen Docetaxel and cisplatin in patients with locally advanced head and neck cancer.Timepoint: safety profile at every cycle