CTRI/2021/03/032390.

Study name	A study to evaluate the role of chemotherapy (which administered of therapeutic agents before a main treatment) in oral cavity cancer patients
Methods	Open label, parallel‐group randomised clinical trial using computer‐generated randomisation
Participants	Inclusion criteria: previously untreated biopsy‐proven, buccal mucosa/gingivobuccal sulcus/tongue or floor mouth cancers requiring mandibular resection as assessed by two surgeons independently; age than 18 years to 70 years; performance status 0 or 1 (ECOG) or KPS 80 or more; adequate organ function ‐ normal bone marrow function (haemoglobin > 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); no history of underlying medical disease that might interfere with systemic therapy
Interventions	Neoadjuvant chemotherapy versus standard care 2 cycles of 3 drug neoadjuvant chemotherapy NACT drug regimen: docetaxel at 75 mg/m2 IV at day ‐1, cisplatin at 75 mg/m2 IV at day ‐1, 5‐FU ‐ 750 mg/m2 IV at day 1‐5.  All patients will receive GCSF following chemotherapy. Patient will be reassessed after 2 cycles of chemotherapy. Those having [unclear] will be given 3rd cycle of chemotherapy before surgery.  Control: standard care: patients receive upfront surgery followed by chemoradiation; patients with other adverse features will receive adjuvant radiotherapy
Outcomes	Primary: disease‐free survival Secondary: mandible preservation, overall survival, progression‐free survival, quality of life, toxicity profile  At  6 years
Starting date	Unclear. Date of registration: 30 March 2021
Contact information	Dr Devendra Chaukar, Tata Memorial Hospital, Mumbai dchaukar@gmail.com
Notes