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To study the effect of novel low dose chemotherapy in oral cancer patients

Maintenance metronomic chemotherapy following standard surgery and adjuvant treatment in locally advanced oral Squamous cell carcinoma.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/01/030256
Enrollment
378
Registered
2021-01-05
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx

Interventions

None listed

Sponsors

Dr Naveena Kumar AN
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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 e. AST(SGOT)/ALT(SGPT) f. Adequate renal function with Creatinine clearance > 30 ml/min

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
disease free survival, demographical, epidemiological and clinical data of locally advanced oral cancer.Timepoint: 3 years

Secondary

MeasureTime frame
Gene expression and mRNA profile, preclinical study dataTimepoint: 3 years

Countries

India

Contacts

Public ContactDr Mahadev Rao

Manipal College of Pharmaceutical Sciences Manipal Academy of Higher Education

mahadev.rao@manipal.edu8105706060

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026