Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx
Conditions
Interventions
Intervention1: Paclitaxel-carboplatin with triple oral metronomic chemotherapy (methotrexate, celecoxib and erlotinib) and low-dose nivolumab (PCm-IO).: Patients will receive Paclitaxel (80 mg/m2) plu
Sponsors
Tata Memorial Centre
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects must have borderline resectable oral cancer 2. Age: Male or female subjects aged equal to or more than 18 years 3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 4. Subjects must have acceptable organ and marrow function as per institutional standards 5. Contraception: Highly effective contraception for both male and female subjects throughout the study and for at least 30 days after the last treatment administration, if the risk of conception exists. The effects of the chemotherapy drugs on the developing human fetus are teratogenic. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. 6. Willing and able to comply with all study requirements, including treatment, able to be followed up at regular intervals and/or required assessments. 8. Ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
Exclusion criteria: 1. Subjects who are receiving any other investigational agents. 2. Pregnant women are excluded from this study. Based on its mechanism of action, chemotherapy can cause fetal harm when administered to a pregnant woman. Therefore, potential risks of administering chemotherapy during pregnancy include increased rates of abortion or stillbirth. Women of reproductive potential must be advised to use effective contraception during treatment and for at least one month after the last dose. 3. Lactating females: Since many drugs are excreted in human milk, it is advised that a lactating woman should not breastfeed during treatment and for at least one month after the last dose due to the potential for serious adverse reactions in breastfed infants.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the event free survival Timepoint: From the date of randomization until first observation of disease recurrence/progression. Assessmnet will be done after every 2 cycles . | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To compare the overall survival 2. To compare the objective response rate post 2 cycles according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 3. To assess and compare the safety and tolerability of the two NACT regimens 4. QOL comparison between two armsTimepoint: 1. Overall Survival(OS)- Every three months follow until death of a patient 2. Objective Response Rate (ORR)- Every 2 cycles 3. Safety and Tolerability- Starting from the date of the first dose of study drug administration up to 30 days after the last dose of study drug administration, or until the time of surgery 4. QOL comparison- Baseline , after completion of NACT , after 3 month, 6 month , 9 month , 12 month , 16 month ,20 month ,24 month;Tertiary Outcome:Timepoint: Baseline, After completion of chemotherapy, Post surgery, after CTRT and at time of recurrence | — |
Countries
India
Contacts
Public ContactDr Vanita Noronha
Tata Memorial Hospital
Outcome results
None listed