eoadjuvant Chemo-Immunotherapy using Carboplatin, Paclitaxel, Oral Metronomic Chemotherapy and Low Dose Nivolumab for Locally Advanced Borderline Resectable ? Oral Cavity squamous cellcarcinoma - A Prospective Study - NeoLOCUS

CMC Vellore Fluid Research Grant0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年7月22日

试验速览

暂无简介。

•Inclusion Criteria: Patients with newly diagnosed Locally Advanced Oral Cavity cancers fitting the below criteria:
•1. Adults more than 18 years of age with ECOG Performance Status 0-1
•2. Clinical AJCC Eighth edition stage III to IVB
•3. Biopsy-proven Oral cavity squamous cell carcinoma
•4. Deemed Borderline Resectable ? in MDT
•5. Written informed consent obtained from subject or subject’s legal representative and ability for subject to comply with the requirements of the study
•6. Required initial laboratory parameters:
•Neutrophils more than 1,500/cu.mm; Platelets more than 100,000/cu.mm; Hemoglobin more than 8g/dl; Estimated creatinine clearance more than 30 ml/min (Cockcroft Gault formula)

•1. Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
•2. Prior treatment with chemotherapy, surgery, or radiation therapy for the current oral cavity cancer
•3. Major surgical procedure within 28 days prior to randomization or anticipation of need for major surgery during the course of study other than that required for the cancer treatment itself
•4. Documented baseline neuropathy CTCAE v5.0 grade 2 or worse
•5. Patients with congestive heart failure symptomatic NYHA class III or worse
•6. Pre-treatment documented LV dysfunction and/or ejection fraction less than 50%

发起方

CMC Vellore Fluid Research Grant