Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Intervention1: Neoadjuvant systemic therapy: Arm B (Experimental Arm)
Patients in Arm B will receive metronomic chemotherapy (tablet erlotinib 150 mg (fixed dose) PO OD daily, capsule celecoxib 200 mg
Sponsors
Tata Memorial Centre
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects must have T3 N1/N2/N3 or T4 HNSCC of the oral cavity 2. Age: Male or female or transgender subjects aged more than 18 years. 3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 2. 4. Subjects must have normal organ and marrow function as per institute protocols 5. Patients with HIV are potentially eligible, as long as they have a CD4 count 200, are on concurrent HAART (highly active antiretroviral therapy), and have absence of active AIDS defining conditions. 6. Both men and women of all races and ethnic groups are eligible for this study. 7. Willing and able to comply with all study requirements, including treatment, able to be followed up at regular intervals and or nature of 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. Within 2 weeks of administration of a chemotherapeutic agent. 3. Current use of immunosuppressive medication, EXCEPT for the following: a. intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection); b. Systemic corticosteroids at physiologic doses less than 10 mg/day of prednisone or equivalent; c. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication) d. Steroids for raised intracranial pressure due to the disease itself e,Steroid use for avoidance or treatment of emesis. 4. Uncontrolled comorbidities including active autoimmune disease that might deteriorate when receiving a chemotherapeutic agent. Clinically significant (i.e., active) cardiovascular disease: cerebrovascular accident/stroke (less 6 months prior to enrollment), myocardial infarction (less 6 months prior to enrollment), unstable angina, congestive heart failure ( New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication. Patients with severe renal and liver dysfunction Child Pugh B or C 5. Prior organ transplantation including allogeneic stem-cell transplantation. 6. Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI-CTCAE v5.0 Grade 3). 7. Pregnant and lactating women are excluded from this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the disease-free survival between the 2 armsTimepoint: 3 years | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the overall survival between the 2 arms b. To compare the adverse event rates between the 2 arms c. To determine the margin assessment between and within the 2 arms d. To compare the cost utility and economic evaluation between the 2 arms Timepoint: From completion of treatment to 3 year | — |
Countries
India
Contacts
Public ContactArjun Singh
TATA MEMORIAL CENTRE
Outcome results
None listed