Comparing Effectiveness and Side Effects of Methotrexate Alone versus Methotrexate Plus Gefitinib in Oral Cancer Patients who have advanced stage and low general condition.

A Prospective Comparative Study Evaluating Efficacy, Compliance and Safety of Weekly Intravenous Methotrexate with or without Oral Gefitinib in Advanced and Metastatic Carcinoma Oral Cavity Patients, Inoperable and Ineligible for Intensive Chemotherapy. - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/01/101914

Enrollment

200

Registered

2026-01-23

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-02

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

Conditions

Health Condition 1: C069- Malignant neoplasm of mouth, unspecified

Interventions

Intervention1: METHOTREXATE PLUS GEFITINIB: Weekly intravenous Methotrexate 40 mg/m2 plus oral Gefitinib 250 mg once daily Control Intervention1: METHOTREXATE: Weekly intravenous Methotrexate 40 mg/m2

Eligibility

Inclusion criteria

Inclusion criteria: 1.Histologically confirmed metastatic or advanced oral cavity squamous cell carcinoma 2.Age equal to or more than 18 years 3.ECOG performance status 3 or higher 4.Patients might or might not have received local radiotherapy 5.Ineligibility for intensive chemotherapy due to comorbidities or poor performance status 6.Written informed consent 7.Blood parameters within normal limits

Exclusion criteria

Exclusion criteria: 1.Prior treatment with EGFR inhibitors 2.Active interstitial lung disease 3.Several renal or hepatic dysfunction 4.Pregnancy or breast feeding

Design outcomes

Primary

Measure	Time frame
Objective response rates (ORR)Timepoint: 3 months, 6 months, 9 months	—

Secondary

Measure	Time frame
1.Treatment compliance 2.Toxicity profiles 3.Progression free survival Timepoint: 4 weeks, 8 weeks, 3 months, 6 months, 9 months, 12 months, 2 years	—

Countries

India

Contacts

Public ContactShyam Sundar Adhikary

Bankura Sammilani Medical College and Hospital

adhikaryshyamsundar69@gmail.com9831360672

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026