eoadjuvant Chemo-Immunotherapy using Carboplatin, Paclitaxel, Oral Metronomic Chemotherapy and Low Dose Nivolumab for Locally Advanced Borderline Resectable ? Oral Cavity squamous cell carcinoma - A Prospective Study
- Conditions
- Health Condition 1: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx
- Registration Number
- CTRI/2023/04/051617
- Lead Sponsor
- CMC Vellore Fluid Research Grant
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
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%
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess proportion of patients who will undergo R0 resection after planed Neoadjuvant chemo-immunotherapy in patients with Locally advanced Oral Cavity Squamous cell carcinoma who were deemed Borderline Resectable ? at baselineTimepoint: 9 weeks from the date of start of chemoimmunotherapy
- Secondary Outcome Measures
Name Time Method