| CTRI Number |
CTRI/2026/01/101914 [Registered on: 23/01/2026] Trial Registered Prospectively |
| Last Modified On: |
22/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing Effectiveness and Side Effects of Methotrexate Alone versus Methotrexate Plus Gefitinib in Oral Cancer Patients who have advanced stage and low general condition. |
|
Scientific Title of Study
|
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. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shyam Sundar Adhikary |
| Designation |
Assistant Professor |
| Affiliation |
Bankura Sammilani Medical College and Hospital |
| Address |
Department of Radiation Oncology;
Cancer Building, Ground Floor
Bankura Sammilani Medical College and Hospital;
P.O.- Kenduadihi;
DIST.- Bankura;
PIN-722102; WEST BENGAL
Bankura
WEST BENGAL
722102
India |
| Phone |
9831360672 |
| Fax |
|
| Email |
adhikaryshyamsundar69@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shyam Sundar Adhikary |
| Designation |
Assistant Professor |
| Affiliation |
Bankura Sammilani Medical College and Hospital |
| Address |
Department of Radiation Oncology;
Cancer Building, Ground Floor
Bankura Sammilani Medical College and Hospital;
P.O.- Kenduadihi;
DIST.- Bankura;
PIN-722102; WEST BENGAL
Bankura
WEST BENGAL
722102
India |
| Phone |
9831360672 |
| Fax |
|
| Email |
adhikaryshyamsundar69@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shyam Sundar Adhikary |
| Designation |
Assistant Professor |
| Affiliation |
Bankura Sammilani Medical College and Hospital |
| Address |
Department of Radiation Oncology;
Cancer Building, Ground Floor
Bankura Sammilani Medical College and Hospital;
P.O.- Kenduadihi;
DIST.- Bankura;
PIN-722102; WEST BENGAL
Bankura
WEST BENGAL
722102
India |
| Phone |
9831360672 |
| Fax |
|
| Email |
adhikaryshyamsundar69@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bankura Sammilani Medical College and Hospital;
P.O.- Kenduadihi;
DIST.- Bankura;
PIN-722102; WEST BENGAL
India.
|
|
|
Primary Sponsor
|
| Name |
Shyam Sundar Adhikary |
| Address |
Department of Radiation Oncology;
Cancer Building, Ground Floor
Bankura Sammilani Medical College and Hospital;
P.O.- Kenduadihi;
DIST.- Bankura;
PIN-722102; WEST BENGAL
|
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Shyam Sundar Adhikary |
Bankura Sammilani Medical College and Hospital |
Department of Radiation Oncology; Cancer Building, Ground Floor Bankura Sammilani Medical College and Hospital; P.O.- Kenduadihi; DIST.- Bankura; PIN-722102; WEST BENGAL
Bankura
WEST BENGAL
722102
India
Bankura
WEST BENGAL |
9831360672
adhikaryshyamsundar69@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE OF BANKURA SAMMILANI MEDICAL COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C069||Malignant neoplasm of mouth, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
METHOTREXATE |
Weekly intravenous Methotrexate 40 mg/m2 |
| Intervention |
METHOTREXATE PLUS GEFITINIB |
Weekly intravenous Methotrexate 40 mg/m2 plus oral Gefitinib 250 mg once daily |
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
80.00 Day(s) |
| Gender |
Both |
| Details |
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 |
|
| ExclusionCriteria |
| Details |
1.Prior treatment with EGFR inhibitors
2.Active interstitial lung disease
3.Several renal or hepatic dysfunction
4.Pregnancy or breast feeding |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Objective response rates (ORR) |
3 months, 6 months, 9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Treatment compliance
2.Toxicity profiles
3.Progression free survival
|
4 weeks, 8 weeks, 3 months, 6 months, 9 months, 12 months, 2 years |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
09/02/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Oral cavity squamous cell carcinoma is a prevalent malignancy with a poor prognosis in advanced stages. Traditional chemotherapy regimens, such as cisplatin, are often not feasible for patients with compromised performance status or comorbidities. Effective, affordable, and well-tolerated palliative treatments are therefore essential to improve overall survival and quality of life. Metronomic therapy is one of the proven methods for treatment of terminally ill patients with malignancy, who are otherwise not fit for chemotherapy. Methotrexate, a folate antagonist, has been utilized in low-dose regimens for palliation. Approximately 80-90% of head and neck squamous cell carcinoma exhibit increased expression or contain genetic variations in EGFR. Hence Gefitinib, and EGFR inhibitor, has potential in enhancing treatment efficacy. Combining these agents may offer improved outcomes without the need for intensive chemotherapy.
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