Health Condition 1: C069- Malignant neoplasm of mouth, unspecified Health Condition 2: C029- Malignant neoplasm of tongue, unspecified
Conditions
Interventions
Intervention1: CHEMO-IMMUNOTHERAPY ARM [Carboplatin + Paclitaxel + OMT (Tab. Methotrexate 9 mg/m2 once weekly + Tab. Celecoxib 200mg BD+ Erlotinib 100mg OD) + Nivolumab]
: Inj. Carboplatin AUC5 IV q 2
Sponsors
CMC Vellore
Eligibility
Inclusion criteria
Inclusion criteria: Age more than 18 years. ECOG performance status of 0 or 1. Documented histologically confirmed Oral cavity squamous cell carcinoma (OCSCC). Fulfills definition of ââ?¬Ë?technically unresectableââ?¬• disease by following criteria:1.Buccal mucosa primary with peritumoral edema extending upto the zygomatic arch. 2.Tongue primary (anterior 2/3rd) extending upto the level of the hyoid bone. 3.Tongue (anterior 2/3rd) extending posteriorly upto the valeculla. 4.Tumour extending into the infra temporal fossa, as defined by an axial plane passing at the level of the sigmoid notch. 5.Skin involvement precluding negative margins. Written informed consent obtained from subject and ability for subject to comply with the requirements of the study. Required initial laboratory parameters: 1.Granulocytes greater than 1000cells/cumm. 2. Platelets greater than 1,00,000 cells/cumm. 3. Normal serum electrolytes. 4. Estimated glomerular filtration rate greated than 60ml/min. 5. Normal PT, APTT 6. Serum ALT less than 2.5 times the upper limit of normal.
Exclusion criteria
Exclusion criteria: Metastatic disease. Prior treatment with chemotherapy or radiation therapy or resection of tumor. History of severe allergic reaction to carboplatin, cisplatin, other platinum-containing formulations, or paclitaxel, methotrexate or celecoxib, sulfonamides, aspirin, other NSAIDs, or any component of the formulation. Patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs Patients with congestive heart failure symptomatic NYHA class greater than III Pretreatment LV dysfunction or EF less than 50% Patients with psoriasis, rheumatoid arthritis or polyarticular-course juvenile idiopathic arthritis Chronic liver disease Hepatitis B, HIV positive Pregnancy or lactation or unwilling to practice birth control during participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the efficacy as measured by R0 resection rate of the study regimen as compared to standard treatment in patients with advanced OCSCCTimepoint: At surgery done at week 8 or week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| a.To compare the tolerability- as assessed by the treatment completion rate and grade 3 adverse event rate in each treatment arm. b.To compare the event free survival (EFS) and overall survival (OS) among the patients in each treatment arm. Timepoint: a. During chemotherapy at each doctor visit b. During follow up visits post treatment | — |
Countries
India
Contacts
Public ContactAjoy Oommen John
CMC Vellore
Outcome results
None listed