Health Condition 1: null- Patients with locally advanced oral cancers post surgery and appropriate adjuvant treatment
Conditions
Interventions
Intervention1: In arm B adjuvant metronomic would be administered.: Metronomic chemotherapy is the study intervention in this trial. The metronomic chemotherapy constitutes of methotrexate and celecox
unless prohibitive toxicity or disease progression occurs prior. will be delivered.
Control Intervention1: In arm Aobservation would be done. The schedule of observation will be in accordance with
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1. Participants must be post surgery and adjuvant RT/CTRT for a histologically confirmed squamous cell cancers of the head and neck region. 2. Participants must have no gross residual disease on clinical examination post 1-2 months of completion of adjuvant treatment. 3. Participants must have malignancy arising from the oral cavity 4. Age : Any age above 18 years. No maximum age. 5. ECOG performance status 6. 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 7. The effects of oral metronomic chemotherapy ( inclusive of methotrexate) on the developing human fetus are teratogenic. Hence women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 6 months after completion of protocol. 8. Both men and women of all races and ethnic groups are eligible for this trial. 9. Willing and able to comply with all study requirements, including treatment (able to swallow tablets), able to be followed up at regular intervals and/or nature of required assessments (e.g. able to have IV contrast if this is required for tumour assessments) 10. Ability to understand and the willingness to sign a written informed consent document
Exclusion criteria
Exclusion criteria: 1. Participants who are receiving any other investigational agents. 2. Primary sites of malignancy in larynx or oropharynx or major salivary gland or nasopharynx or skin 3. Patients with QTc prolongation defined as QTc interval greater than 480 ms in view of risk of sudden cardiac death associated with use of celecoxib. 4. Patients receiving methotrexate for other indications not limited to rheumatoid arthritis 5. Patients who had received long term Cox-2 inhibitors ( more than 3 month continuous usage) will be excluded 6. History of allergic reactions attributed to compounds of similar chemical or biologic composition to any agents used in study. 7. Uncontrolled intercurrent illness including, but not limited to, hypertension, tuberculosis, diabetes, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, renal failure (on dialysis), active gastrointestinal bleeding, cerebrovascular accidents, 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. 8. Pregnant women and breastfeeding women are excluded from this study because celecoxib / erlotinib and methotrexate are agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants. These potential risks may also apply to other agents used in this study. 9. HIV-positive, Hepatitis B and C seropositive patients are excluded from this study. 10. Patients with previous history of other cancers within last 2 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. 2 year OS : OS will be defined time in days between date of randomization to date of death. Patients alive at their last follow ups would be censored. The 2 year OS would be estimated by Kaplan meier analysis and would be compared between the 2 arms by the log rank testTimepoint: at two year post treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. 2 year PFS : PFS will be defined time in days between date of randomization to date of progression or death whichever is earlier. Patients who have not progressed or died at their last follow ups would be censored.The median PFS would be estimated by Kaplan meier analysis and would be compared between the 2 arms by the log rank test.Timepoint: in days between date of randomization to date of progression or death whichever is earlier | — |
Countries
India
Contacts
Public ContactDr Pankaj Chaturvedi
Tata Memorial Hospital
Outcome results
None listed