Health Condition 1: null- Locally advanced borderline operable sqamous cell carcinomas of oral cavity
Conditions
Interventions
Intervention1: Not applicable: not applicable
Intervention2: na: na
Intervention3: Neo Adjuvant Chemotherapy: Two cycles of 3 drug Neo adjuvant chemotherapy followed by surgery and adjuvant chemoradia
Sponsors
DAECTC
Eligibility
Inclusion criteria
Inclusion criteria: 1. Previously untreated and biopsy proven stage III and IV squamous cell carcinoma of oral cavity (T3, T4 � N 3cm) requiring segmental mandibular resection. 2. Performance status � 0 or 1(ECOG) or KPS 80 or more. 3. Age - 18 years. 4. Adequate organ function � Normal bone marrow function (Hemoglobin 8 gm/dL, Total leucocyte count 3000/cumm, Absolute neutrophil count 1500/cumm, platelet count 100,000/cumm), normal renal function (normal serum creatinine and calculated creatinine clearance 60ml/min), normal liver function tests (Total Bilirubin �not more than 2 mg/dL, transaminases 5 times upper limit of normal, serum albumin 3 gm/dL) 5. No history of underlying medical disease which might interfere with systemic therapy.
Exclusion criteria
Exclusion criteria: 1. Gross mandibular invasion. 2. Females with childbearing potential should be willing to use contraception. Pregnant females will not be enrolled. 3. Patients unwilling to give written informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcome: Mandible Preservation ratesTimepoint: 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Outcome: 1)Quality of Life 2)Overall Survival 3)Disease Free SurvivalTimepoint: 2 years | — |
Countries
India
Contacts
Public ContactDr Devendra Chaukar
TATA MEMORIAL HOSPITAL
Outcome results
None listed