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Role of affordable oral cancer drugs in advanced mouth cancer - Feasibility study.

Low cost, oral, metronomic therapy protocol in locally advanced oral cancers - Feasibility study.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/09/021263
Enrollment
50
Registered
2019-09-16
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: C06- Malignant neoplasm of other and unspecified parts of mouth

Interventions

Intervention1: Drugs - Methotrexate and Celecoxib: Methotrexate Dose - 15 mg/m2 of BMI once a week Duration - 8 weeks Route - Oral Celecoxib Dose -200 mg twice daily Duration - 8 weeks Route - Oral

Sponsors

All India Institute of Medical Sciences Bhubaneswar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. All locally advanced borderline resectable / inoperable carcinomas of oral cavity presenting to AIIMS, Bhubaneswar. 2. All patients more than 18 years of age. 3. Histopathologically proven squamous cell carcinoma. 4. Patients giving consent for the planned oral neoadjuvant chemotherapy

Exclusion criteria

Exclusion criteria: 1. Patients refusing to give consent. 2. Tumors of other than squamous histology. 3. Patients not complying with the planned chemotherapy. 4. Patients who have received primary treatment before. 5. Patients with second primary tumors.

Design outcomes

Primary

MeasureTime frame
To study the feasibility of low cost, oral metronomic therapy in locally advanced borderline oral cancers.Timepoint: 4 weeks and 8 weeks

Secondary

MeasureTime frame
To study the compliance and tolerance of the oral metronomic therapy being given to the patients. To study the toxicity profile and efficacy of the oral metronomic therapy being given to the patients. To evaluate the response rate in the management of these patients. Timepoint: 4 weeks and 8 weeks

Countries

India

Contacts

Public ContactDr Mahesh Sultania

All india Institute of Medical Sciences, Bhubaneswar

drmaheshsultania@gmail.com9999330769

Outcome results

None listed

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