Health Condition 1: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx
Conditions
Interventions
Intervention1: Arm A – Paclitaxel plus Carboplatin (Chemotherapy)
Arm B - Paclitaxel plus Carboplatin (Chemotherapy) with Tab Celecoxib 200 mg PO twice daily, erlotinib
(150 mg PO OD) plus Tab Methotr
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1. Head and neck squamous cancers (any grade) planned for palliative chemotherapy 2. Age : Any age =18 years 3. ECOG performance status =2 4. Histopathologically or FNAC (Fine needle aspiration cytology) proof of cancer. 5. Participants must have normal organ and marrow function 6. Willing and able to comply with all study requirements
Exclusion criteria
Exclusion criteria: 1. Participants who are currently receiving any other investigational agents. 2. Platinum refractory failure (failure within 6 months of reception of cisplatin or carboplatin as a part of multimodality curative treatment) or early failure (failure within 1 month of surgery or radiation). 3. Patients with QTc prolongation. . 4.. Uncontrolled intercurrent illness 5.. Pregnant women and breastfeeding women are excluded from this study because Chemotherapy agents have the potential for teratogenicity or abortifacient effects
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the Overall Survival between the armsTimepoint: 5 years | — |
Secondary
| Measure | Time frame |
|---|---|
| a. To compare the median progression free survival (PFS) between the arms b. To compare the QOL between the arms c. To compare the CTCAE version 5 adverse events between the arms d. To compare the response rate & disease control rate between the armsTimepoint: 5 years | — |
Countries
India
Contacts
Public ContactDr Vanita Noronha
Tata Memorial Hospital
Outcome results
None listed