Two drug therapy versus three drug therapy in resectable locally advanced oral cavity cancer
- Conditions
- Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx
- Registration Number
- CTRI/2024/07/071188
- Lead Sponsor
- AIIMS, New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Histologically confirmed squamous cell carcinoma of the oral cavity
Patients with a resectable lesion, with clinical stage III or IVA disease (T3N0 or T1-3N1-2M0 or T4aN0-2M0 according to Union for International Cancer Control [2018]).
ECOG PS 0-1
Meeting the following standard values of general laboratory tests completed within 7 days prior to randomization and values are within the parameters required by the protocol:
a) WBC count more than 4,000/µL, hemoglobin more than 8 g/L, platelet count more than 100,000/µL
b) ALT and AST less than 2.5× the upper limit of normal
c) Total bilirubin less than 1.5× the upper limit of normal
d) Serum creatinine less than 1.5× the upper limit of normal
Written informed consent.
Distant metastasis or other cancers
Have undergone surgery involving primary tumor or lymph nodes (except diagnostic biopsy)
Have received any prior radiotherapy or chemotherapy
Have had other malignancies within 5 years
Have creatinine clearance less than 60 mL/min.
Cisplatin ineligible patients
Unstable angina within 3 weeks, or with a history of myocardial infarction within last 6 months
Pregnant or breastfeeding females or those not willing for contraception
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method