Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Intervention1: Neo Adjuvant Chemotherapy: Two cycles of 3 drug Neo adjuvant Chemotherapy NACT drug regimen:
1.Docetaxel ââ?¬â??75mg/m2 IV Day-1.
2.Cisplatin- 75mg/m2 IV Day-1.
3.5FU ââ?¬â??750mg/m2
Sponsors
National Cancer Grid
Eligibility
Inclusion criteria
Inclusion criteria: 1. Previously untreated biopsy proven Squamous Cell Carcinoma, buccal mucosa / gingivobuccal sulcus/Tongue or Floor Mouth cancers requiring mandibular resection as assessed by two surgeons independently. 2. Age between 18 years â?? 70 years 3. Performance status â?? 0 or 1(ECOG) or KPS 80 or more. 4. Adequate organ function â?? Normal bone marrow function (Hemoglobin >8 gm/dL, total leucocyte count >3000/cu mm, absolute neutrophil count >1500/cu mm, platelet count >100,000/cu mm), normal renal function (normal serum creatinine and calculated creatinine clearance >60ml/min), normal liver function tests (Total Bilirubin â??not more than 2 mg/dL, transaminases 3 gm/dL) 5. No history of underlying medical disease which might interfere with systemic therapy. 6. Patients with superficial cortical erosion of the mandible without clinical or radiological evidence of deep mandibular invasion, and with para mandibular disease necessitating segmental resection are eligible.
Exclusion criteria
Exclusion criteria: 1. Clinical and/or radiological evidence of mandibular invasion. 2. Patients with deep mandibular invasion, including medullary bone involvement or extensive cortical destruction on clinical examination or radiological imaging, are excluded. 3. Recurrent cancers/history of head neck malignancy in previous 5 years 4. Females with childbearing potential should be willing to use contraception. Pregnant females will not be enrolled. 5. Patients unfit for chemotherapy- Uncontrolled intercurrent illness including, but not limited to, active tuberculosis, uncontrolled diabetes, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, renal failure (on dialysis), active gastrointestinal bleeding, cerebrovascular accidents within last 1 year, inflammatory bowel disease, known hyperkalemia (CTCAE version 5.0 grade 3 or above which ispersistent over 1 week) or psychiatric illness/social situations that would limit compliancewith study requirements. Patients who have uncontrolled hypertension or diabetes orother chronic medical condition at initial evaluation but in whom these conditions arecontrolled with medical intervention can be assessed for eligibility. Participants must have normal organ and marrow function as defined below: a. Leukocytes less than 3,000/mcL b. Platelets less than100,000/mcL c. Total bilirubin more than 2 times Ã? institutional upper limit of normal d. AST(SGOT)/ALT(SGPT) more than 2 times Ã? institutional upper limit of normal e. Calculated Creatinine clearance less than 30 ml/min 6. Patients unwilling to give written informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ââ?¬Â¢Disease Free Survival ââ?¬â??Disease free survival will be measured from date of randomization to date of recurrence or date of death and patients who have not progressed will be censored at the date of last follow up.Timepoint: 10 years i.e. 8 years of accrual + 2 years of follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| ââ?¬Â¢ Mandible Preservation ââ?¬Â¢ Overall Survival ââ?¬â?? ââ?¬Â¢ Progression free survival ââ?¬â?? ââ?¬Â¢ Quality of Life- ââ?¬Â¢ Toxicity profile -Timepoint: 10 Years i.e 8 years of accrual & 2 years of follow up | — |
Countries
India
Contacts
Public ContactDr ShivaKumar Thiagarajan
Tata Memorial Hospital
Outcome results
None listed