To study the effect of novel low dose chemotherapy in oral cancer patients
- Conditions
- Health Condition 1: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx
- Registration Number
- CTRI/2021/01/030256
- Lead Sponsor
- Dr Naveena Kumar A
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Locally advanced primary oral SCC who underwent curative surgery (pT3 and above, pN1 and above).
2. Age more than 18 years.
3. Patients with normal organ and marrow function as below
a. Hemoglobin > 8 g/L
b. Total WBC >= 3000/mcL or Absolute neutrophil count (ANC) > 1.5 x 109/L
c. Platelets >= 100000/mcL
d. Total bilirubin < 2 Ã? institutional upper limit of normal
e. AST(SGOT)/ALT(SGPT) <=2.5 Ã? institutional upper limit of normal
f. Adequate renal function with Creatinine clearance > 30 ml/min
1. Early SCC oral cavity (pT1, pT2, pN0)
2. Patient with locally advanced SCC oral cavity, who have not received standard surgery and/or adjuvant treatment.
3. Recurrent/second primary oral malignancy
4. Age more than 80 years
5. Pregnant women
6. Patient not fit for Metronomic chemotherapy
7. Patients with QTc prolongation defined as QTc interval greater than 0.5 seconds (celecoxib associated sudden cardiac death)
8. Patient not giving informed consent
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method disease free survival, demographical, epidemiological and clinical data of locally advanced oral cancer.Timepoint: 3 years
- Secondary Outcome Measures
Name Time Method Gene expression and mRNA profile, preclinical study dataTimepoint: 3 years