Health Condition 1: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx
Conditions
Interventions
Intervention1: Chemotherapy and low dose immunohterapy: Neoadjuvant chemo-immunotherapy with Carboplatin (AUC 5), Nab-Paclitaxel (175mg/m2) and Low Dose Nivolumab (weight based dosing: 20mg for less t
40mg for more than 65kg) given 3-weekly for 2 cycles, Triple Oral metronomic chemotherapy with Tab Erlotinib 100mg daily, Tab Methotrexate 9mg/m2 weekly once, Tab Celecoxib 200mg twice daily until com
Sponsors
CMC Vellore Fluid Research Grant
Eligibility
Inclusion criteria
Inclusion criteria: 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)
Exclusion criteria
Exclusion criteria: 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%
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Distant disease-free survival, defined as time from start of treatment to the earliest occurrence of invasive distant recurrences and/or death (from oral cancer, from a non-oral cancer, or from an unknown cause)Timepoint: 2 years from date of diagnosis;Incidence of laboratory and clinical adverse events recorded and graded according to CTCAE v5.0.Timepoint: During and After each cycle of chemo-immunotherapy;Invasive disease-free survival, defined as time from start of treatment to the earliest occurrence of invasive local, regional, or distant recurrences, new primary invasive cancers and death (from oral cancer, from a non-oral cancer, or from an unknown cause)Timepoint: 2 years from date of diagnosis;Overall survival, time from start of treatment to death (from oral cancer, from a non-oral cancer, or from an unknown cause)Timepoint: 2 years from date of diagnosis;Pathological response of the tumor will be assessed for patients undergoing surgery using the following 2 systems: • Japanese Head and Neck Society system • AJCC 8th edition TNM pathological stagingTimepoint: At the time of post operative histopathological examination;Proportion of patients completing at least 2 cycles of planned chemo-immunotherapyTimepoint: By end of planned chemo-immunotherapy;Quality of life will be assessed using the EORTC QLQ-C30 HN35 questionnaireTimepoint: at baseline and post treatment at various timepoints 3 months, 6 months, 1 year and 2 years;Radiological Response rateTimepoint: Compare baseline scans and reassessment scans done at 2-3 weeks after planned neoadjuvant chemoimmunotherapy based on RECIST 1.1 | — |
Countries
India
Contacts
Public ContactPraveen Kumar Marimuthu
Christian Medical College, Vellore
Outcome results
None listed