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Clinical Trials/CTRI/2021/01/030256
CTRI/2021/01/030256
Not yet recruiting
未知

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

Dr Naveena Kumar A0 sites0 target enrollmentTBD

Overview

Phase
未知
Intervention
Not specified
Conditions
Health Condition 1: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx
Sponsor
Dr Naveena Kumar A
Status
Not yet recruiting
Last Updated
4 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Observational

Investigators

Sponsor
Dr Naveena Kumar A

Eligibility 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 \< 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

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

Outcomes

Primary Outcomes

Not specified

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