A Study to evaluate the role of chemotherapy (which administered before Surgery.) in oral cavity cancer patients

Phase 3

• Conditions: Health Condition 1: O- Medical and Surgical

• Registration Number: CTRI/2021/03/032390
• Lead Sponsor: ational Cancer Grid

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 13 November 2023

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Previously untreated biopsy proven, buccal mucosa / gingivobuccal sulcus/Tongue Or Floor Mouth cancers requiring mandibular resection as assessed by two surgeons independently.

2. Age than 18 years – 70 years

3. Performance status – 0 or 1(ECOG) or KPS 80 or more.

4. Adequate organ function – Normal bone marrow function (Hemoglobin >8 gm/dL, total leucocyte count >3000/cumm, absolute neutrophil count >1500/cumm, platelet count >100,000/cumm), normal renal function (normal serum creatinine and calculated creatinine clearance >60ml/min), normal liver function tests(Total Bilirubin –not more than 2 mg/dL, transaminases <5 times upper limit of normal, serum albumin >3 gm/dL)

5. No history of underlying medical disease which might interfere with systemic therapy

Exclusion Criteria

1. Clinical and/or radiological evidence of mandibular invasion.

2. Recurrent cancers/history of head neck malignancy in previous 5 years

3. Females with childbearing potential should be willing to use contraception. Pregnant females will not be enrolled.

4- Patients unfit for chemotherapy-

Uncontrolled intercurrent illness including, but not limited to, active tuberculosis, uncontrolled diabetes, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, renal failure (on dialysis), active

gastrointestinal bleeding, cerebrovascular accidents within last 1 year, inflammatory

bowel disease, known hyperkalemia (CTCAE version 5.0 grade 3 or above which is persistent over 1 week) or psychiatric illness/social situations that would limit compliance with study requirements. Patients who have uncontrolled hypertension or diabetes or other chronic medical condition at initial evaluation but in whom these conditions are controlled with medical intervention can be assessed for eligibility.

Participants must have normal organ and marrow function as defined below:

a. Leukocytes less than 3,000/mcL

b. Platelets less than100,000/mcL

c. Total bilirubin more than 2 times × institutional upper limit of normal

d. AST(SGOT)/ALT(SGPT) more than 2 times × institutional upper limit of normal

e. Calculated Creatinine clearance less than 30 ml/min

5 Patients unwilling to give written informed consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified