Health Condition 1: null- Oral cancers patients
Conditions
Interventions
Intervention1: Arm B (Experimental arm): Patients in arm B would be planned for NACT with TPF for 3 cycles followed by surgery followed by adjuvant RT or CTRT
Control Intervention1: Arm A (Standard ar
Sponsors
TMC Research Administrative Council
Eligibility
Inclusion criteria
Inclusion criteria: 1.Participants must have malignancy arising from either buccal mucosa or oral tongue. a.The tumors arising in gingivobuccal sulcus would be considered as buccal mucosa cancers in this study. 2.Clinical stage grouping Stage III or IV 3.The oral cancer should be deemed resectable 4.ECOG performance status 5.Histopathologically or FNAC 7.Participants must have normal organ and marrow function as defined below a. Leukocytes >=3,000/mcL b.Platelets>=100,000/mcL c.Total bilirubin d.AST(SGOT)/ALT(SGPT) e.Calculated Creatinine clearance > 30 ml/min 8.The effects of chemotherapy on the developing human fetus are teratogenic. Hence women of childbearing potential and men must agree to use adequate contraception
Exclusion criteria
Exclusion criteria: 1. Stage groups T3N0,T1N1, T2N1 2. Stage IVC 3. Patients receiving NACT for mandibular preservation or borderline resectable or technically unresectable status 4. Participants who are receiving any other investigational agents. 5. Patients with QTc prolongation defined as QTc interval greater than 480 ms in view of risk of sudden cardiac death associated with use of ondansetron. Patients in whom an initial evaluation QTc is prolonged but with medical interventions it is restored to normal are eligible for the study. . 6. History of previous malignancy in last 5 years 7. Patients receiving methotrexate medical indications not limited to rheumatoid arthritis or as who have received it either as neoadjuvant or adjuvant within last 2 years. 8. History of allergic reactions attributed to compounds of similar chemical or biologic composition to any agents used in study. 9. Uncontrolled intercurrent illness including, but not limited to, active tuberculosis, uncontrolled diabetes, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, renal failure (on dialysis), active gastrointestinal bleeding, cerebrovascular accidents within last 1 year , inflammatory bowel disease, known hyperkalemia ( CTCAE version 4.02 grade 3 or above which is persistent over 1 week) or psychiatric illness/social situations that would limit compliance with study requirements. Patients who have uncontrolled hypertension or diabetes or other chronic medical condition at initial evaluation but in whom these conditions are controlled with medical intervention can be assessed for eligibility. 10. Pregnant women and breastfeeding women are excluded from this study because Neoadjuvant chemotherapy agents have the potential for teratogenic or abortifacient effects. 11. HIV-positive, Hepatitis B and C seropositive patients are excluded from this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the 5 year overall survival between 2 arms. The primary endpoint would be 5 year OS (Overall survival).Timepoint: at 5 Year | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To compare the 5 year disease free survival between 2 arms. The endpoint is 5 year DFS (Disease free survival) 2. To compare the QOL score at baseline, 6 months, 12 months and at 24 months post treatment completion between the 2 arms. Timepoint: at 6 months, 12 months ,24th Months,at 5 year | — |
Countries
India
Contacts
Public ContactDr Kumar Prabhash
Tata Memorial Hospital
Outcome results
None listed