Metronomic study for Head & Neck cancer
- Conditions
- Health Condition 1: null- Cytologically or pathologically proven squamous cell carcinoma of head and neck. Treatment of the head and neck cancer with palliative intent
- Registration Number
- CTRI/2015/11/006388
- Lead Sponsor
- Tata Memorial Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 422
1. Site:
Cytologically or pathologically proven squamous cell carcinoma of head and neck. Treatment of the head and neck cancer with palliative intent
•Distant metastases from head-neck primary
•Recurrent head-neck cancer presently not amenable to surgery or irradiation (are treated adequately at initial diagnosis)
•Loco-regionally advanced stage disease deemed unsuitable for definitive surgery or radiotherapy (Patient could still be eligible for palliative radiotherapy for symptom relief)
2. Subjects between the ages of 18 - 70 yrs with Karnofsky performance scores >=70
3.Pretreatment normal hematological and biochemical parameters as defined below:
1.Hemoglobin : >= 8 mg/dL
2.Absolute neutrophil count >1500
3.Total Leucocyte counts > 3000
4.Platelet counts: 100,000 - 1000,000 /mm3
5.Creatinine Clearnce more than or equal to 45 ml/min.
4. Baseline liver function test within twice the normal limit for serum bilirubin.Patients should have signed the informed consent form and must be available for follow-up as outlined below.
Exclusion Criteria:
1. Evidence of primary in Thyroid or salivary gland or nasopharynx
2. Patients with significant and uncontrolled co morbid conditions e.g. Diabetes Mellitus, Hypertension, COPD ,active Tuberculosis and HIV positive patients
3. Patients who have received cisplatin within last 3 months
4. Serological positive for HIV,HBV & HCV
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method