A clinical trial to study the effects of three oral drugs in low dose - Methotrexate, Cyclophosphamide and Capecitabine in patients with resectable Head and Neck cancer
Phase 2
- Conditions
- Health Condition 1: C04- Malignant neoplasm of floor of mouthHealth Condition 2: C03- Malignant neoplasm of gumHealth Condition 3: C00- Malignant neoplasm of lipHealth Condition 4: C02- Malignant neoplasm of other and unspecified parts of tongue
- Registration Number
- CTRI/2022/09/045265
- Lead Sponsor
- Swarnava Chanda
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Age > 18 years
Biopsy proven Operable locally advanced oral cavity squamous cell carcinoma(T4a/4b NanyM0)
ECOG performance status 0-2
WBC countââ?°Â¥ 3 Ã?â?? 109 /L with neutrophils ââ?°Â¥ 1.5 Ã?â?? 109/L , platelet count ââ?°Â¥ 1 lakh/mL and Hb ââ?°Â¥ 9 gm/dL
Total Bilirubin � 1.5 times the upper limit of normal range
AST & ALT � 5 times the upper limit of normal range
Patients with measurable disease by RECIST 1.1 criteria
Exclusion Criteria
Inoperable oral cavity carcinoma
[Skull base invasion, prevertebral fascia involvement or carotid encasement]
Metastatic oral cavity carcinoma
Recurrent oral cavity carcinoma
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Among patients diagnosed with operable locally advanced oral cavity squamous cell cancer and receiving metronomic chemotherapy <br/ ><br>To assess the clinical benefit rate <br/ ><br>To assess the toxicity as graded by CTCAE ver 5.0 <br/ ><br>Timepoint: In every 2 weeks of therapy response will be assessed clinically as per RECIST 1.1. <br/ ><br>Toxicity will be assessed at Day 8, Day 15, Day 28, and Day 56 of the therapy.
- Secondary Outcome Measures
Name Time Method 1.To assess the 30 days post surgical morbidity as graded by Clavien Dindo classification <br/ ><br>2.To assess the clinicopathological factors and pre-treatment VEGF gene expression with response <br/ ><br>3.To compare the change in VEGF expression (pre-treatment and post-treatment) with response <br/ ><br>4.To assess the two year disease free survival and overall survival and clinicopathological factors predicting survival <br/ ><br>Timepoint: 1.30 days after surgery <br/ ><br>2.at beginning, at 8 weeks <br/ ><br>3.at beginning, at 8 weeks <br/ ><br>4.2 years