Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx
Conditions
Interventions
Intervention1: Adjuvant methotrexate: Oral Methotrexate 15mg per m2 weekly for 52 weeks
Control Intervention1: Placebo: Placebo weekly for 52 weeks
Sponsors
AIIMS New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria as per protocol
Exclusion criteria
Exclusion criteria: Have second cancers Have had any other malignancies in past Have creatinine clearance less than 60 mL per min Has had any progression post surgical resection and or post operative radiation Methotrexate ineligible patients Unstable angina within 3 weeks, or with a history of myocardial infarction within last 6 months Pregnant or breastfeeding females or those not willing for contraception Post resection margin close margin or positive margin Evidence of any extra-nodal extension in post-surgical specimen
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease free survivalTimepoint: At 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival in both armsTimepoint: At 2 years;Disease specific survival in both armsTimepoint: At 2 years;Locoregional control in both armsTimepoint: At 2 years;Disease free survival in both arms with respect to subsets receiving two drugs versus three drugs neo-adjuvant chemotherapyTimepoint: At 2 years;Adverse events (NCI CTCAE version 5.0) in both armsTimepoint: At 2 years | — |
Countries
India
Contacts
Public ContactAkash Kumar
NCI Jhajjar
Outcome results
None listed