Health Condition 1: null- Advanced carcinoma of Head & NEck
Conditions
Interventions
Intervention1: chemotherapy: 3 weekly cisplatin
Cisplatin 100 mg/m2 IV three weekly, duration is for 6 to 8 weeks
Intervention2: Chemotherapy: Cisplatin 100 mg/m2 3 weekly for 3 cycle. & 3 weekly me
Sponsors
Tata memorial Hospital Mumbai
Eligibility
Inclusion criteria
Inclusion criteria: . Histological or cytological proven diagnosis of squamous cell or undifferentiated carcinoma of the oropharynx, hypopharynx and larynx or squamous cell carcinoma of the head and neck region of unknown primary. 3. Disease is Stage III or IV, with no evidence of distant metastases. 4. ECOG performance status 5. Patients who are candidates for adjuvant concurrent chemoradiotherapy, i.e. tumor histopathology demonstrates close or positive margins, perinodal extension, > 2 lymph nodes positive or T4 primary. 6. Patients with no contraindications to Cisplatin chemotherapy. 7. Patients with no contraindications to radiotherapy. 8. Patients who can give informed consent to participate in the study. 9. Patients who can be followed up and can take all the cycles of chemotherapy at the participating institution. 10. Adequate organ function • Hematological- Hb > 90 g/L, ANC >= 1.5 x 109/L, platelets >= 100 x 109/L. • Liver functions- bilirubin = 30 g/L. • Renal function- Creatinine 50 mL/min. 11. Women of child-bearing age should have a negative pregnancy test at the time of randomization and should be willing to use adequate contraception during the treatment phase of the trial.
Exclusion criteria
Exclusion criteria: 1. Baseline hearing loss,which is moderate or severe.2) Calculated GFR 50 cc/min.3) Patients who have received any neoadjuvant induction chemotherapy 4) Serious co-morbidities such as severe cardiac failure or severe pulmonary compromise or severe and active infection.5) Presence of distant metastatic disease .6) Life expectancy less than 6months.7) Patient with active second malignancies ,apat from skin cancers and cervical intraepithelial neoplasia.8) Patient on other investigatonal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary: Locoregional control Secondary: Toxicity, compliance to treatment, progression-free survival, response rate, overall survival, quality of life Timepoint: Secondary: Toxicity, compliance to treatment, progression-free survival, response rate, overall survival, quality of life | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary: Toxicity,Timepoint: Secondary: Toxicity, compliance to treatment, progression-free survival, response rate, overall survival, quality of life | — |
Countries
India
Contacts
Public Contactswapna samant
Tata Memorial Hospital
Outcome results
None listed