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

Efficacy of metronomic oral capecitabine, methotrexate and cyclophosphamide in locally advanced operable oral cavity squamous cell carcinoma - A Phase II study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/09/045265

Enrollment

Registered

2022-09-06

Start date

Unknown

Completion date

Unknown

Last updated

2024-10-14

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

Conditions

Health Condition 1: C04- Malignant neoplasm of floor of mouth Health Condition 2: C03- Malignant neoplasm of gum Health Condition 3: C00- Malignant neoplasm of lip Health Condition 4: C02- Malignant neoplasm of other and unspecified parts of tongue

Interventions

Intervention1: metronomic oral capecitabine, methotrexate and cyclophosphamide in locally advanced operable oral cavity squamous cell carcinoma: Patients will be started on oral metronomic chemotherap

Eligibility

Inclusion criteria

Inclusion criteria: Age > 18 years Biopsy proven Operable locally advanced oral cavity squamous cell carcinoma(T4a/4b NanyM0) ECOG performance status 0-2 WBC count= 3 × 109 /L with neutrophils = 1.5 × 109/L , platelet count = 1 lakh/mL and Hb = 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

Exclusion criteria: Inoperable oral cavity carcinoma [Skull base invasion, prevertebral fascia involvement or carotid encasement] Metastatic oral cavity carcinoma Recurrent oral cavity carcinoma

Design outcomes

Primary

Measure	Time frame
Among patients diagnosed with operable locally advanced oral cavity squamous cell cancer and receiving metronomic chemotherapy To assess the clinical benefit rate To assess the toxicity as graded by CTCAE ver 5.0 Timepoint: In every 2 weeks of therapy response will be assessed clinically as per RECIST 1.1. Toxicity will be assessed at Day 8, Day 15, Day 28, and Day 56 of the therapy.	—

Secondary

Measure	Time frame
1.To assess the 30 days post surgical morbidity as graded by Clavien Dindo classification 2.To assess the clinicopathological factors and pre-treatment VEGF gene expression with response 3.To compare the change in VEGF expression (pre-treatment and post-treatment) with response 4.To assess the two year disease free survival and overall survival and clinicopathological factors predicting survival Timepoint: 1.30 days after surgery 2.at beginning, at 8 weeks 3.at beginning, at 8 weeks 4.2 years	—

Measure

Time frame

1.To assess the 30 days post surgical morbidity as graded by Clavien Dindo classification 2.To assess the clinicopathological factors and pre-treatment VEGF gene expression with response 3.To compare the change in VEGF expression (pre-treatment and post-treatment) with response 4.To assess the two year disease free survival and overall survival and clinicopathological factors predicting survival Timepoint: 1.30 days after surgery 2.at beginning, at 8 weeks 3.at beginning, at 8 weeks 4.2 years

—

Countries

India

Contacts

Public ContactSwarnava Chanda

JIPMER

drpenumadu@gmail.com9042092936

Outcome results

None listed

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