Health Condition 1: C14- Malignant neoplasm of other and ill-defined sites in the lip, oral cavity and pharynx
Conditions
Interventions
Intervention1: Arm B- Paclitaxel-Carboplatin plus OMCT: Patients will receive Paclitaxel (175mg/m2) plus Carboplatin (AUC 5) on day 1 in 3 weekly cycles. In addition they will receive a fixed dose of
Sponsors
Cancer Research and Statistic Foundation CRSF
Eligibility
Inclusion criteria
Inclusion criteria: 1. Head and neck cancers planned for palliative chemotherapy 2. Any age =18 years 3. ECOG PS =2 4. Histopathologically or fine needle aspiration cytology proof of cancer 5. Normal organ and marrow function
Exclusion criteria
Exclusion criteria: 1. Participants currently receiving any other investigational agents. 2. Platinum refractory failure 3. Patients with QTc prolongation 4. Patients receiving methotrexate for other medical indications 5. History of allergic reactions attributed to compounds used in study. 6. Uncontrolled intercurrent illness 7. Pregnant women and breastfeeding women 8. HIV-positive, Hepatitis B and C seropositive patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall SurvivalTimepoint: Overall Survival will be defined time in months between the date of randomization to date of death. | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free SurvivalTimepoint: Date of randomization to date of progression or death;Quality of lifeTimepoint: Baseline, 2 months,4 months and at 6 months post treatment completion;Adverse EventsTimepoint: CTCAE version 5 worst grade toxicity between the 2 arms during any period of chemotherapy | — |
Countries
India
Contacts
Public ContactDr Ashay Karpe
Cancer Research and Statistics Foundation
Outcome results
None listed