Health Condition 1: null- Patients who have unresectable locally advanced head and neck cancer
Conditions
Interventions
Intervention1: docetaxel with platinum: The DC regimen consisted of cisplatin at a dose of 75 mg/m2, administered as a 1-hour infusion on day 1, and of docetaxel at a dose of 75 mg/m2, administered as
Sponsors
Tata Memorial centre
Eligibility
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically confirmed squamous cell carcinoma of age more than 18 years; 2. Performance status 3. There should not be any prior history of any chemotherapy. 4. There should be at least one lesion that is measurable either unidimensionally or bidimensionally. 5. Tumour has to considered technically unresectable by a multidisciplinary team. 6. Estimated life expectancy of at least 12-weeks. 7. Adequate organ and immune system function as indicated by the following laboratory values, obtained System Lab value Hematologic ANC >= 1.5 Ã? 109 /L Hb >= 8.0 g/dL Platelets >= 100 Ã? 109 /L Renal Sr. Creatinine Hepatic Total Bilirubin AST ALT Alkaline Phosphatase 8. Women of childbearing potential must be willing to consent to using effective contraception (eg, hormonal contraceptives, bilateral tubal ligation, barrier with spermicide, intrauterine device) while on treatment and for at least 3 months thereafter. A man who is the partner of a woman of childbearing potential must be willing to consent to using effective contraception (eg, vasectomy or barrier with spermicide) while on treatment and for 3 months thereafter. 9. Willing and able to comply with all study requirements, including treatment, able to be followed up at regular intervals. 10. Signed, written informed consent
Exclusion criteria
Exclusion criteria: 1. Clinical or radiologic evidence of metastatic disease. 2. Any significant active infection, including chronic active hepatitis B, active hepatitis C, HIV infection with AIDS or immunodeficiency syndromes. 3. Serious uncontrolled medical illness (e.g. uncontrolled diabetes mellitus, uncontrolled hypertension, severe infectionor untreated psychiatric conditions) that might limit the ability of the patient to comply with the protocol. 4. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse. 5. Pregnancy, lactation, or inadequate contraception. Women must be post menopausal, infertile, or willing to use a reliable means of contraception. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to registration. Men must have been surgically sterilised or be willing to use a (double if required) barrier method of contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survivalTimepoint: at two year | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival and Response rateTimepoint: Progression free survival-at one year Response rate-at two months | — |
Countries
India
Contacts
Public ContactDr Kumar Prabhash
Tata Memorial Hospital
Outcome results
None listed