Study evaluating survival benefit of use of low dose continuous chemotherapy drugs along with surgery and radiation in treatment of advanced stage cancers of the oral cavity

Randomised Controlled Trial Assessing Addition of Neoadjuvant and Maintenance Oral Metronomic Chemotherapy to Standard Surgery and Adjuvant Therapy in Stage III/IV Operable Oral Cancers - MCT

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2015/01/005405

Enrollment

400

Registered

2015-01-14

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: null- Operable Oral Cancers Stage III and IV

Interventions

Intervention1: Metronomic Therapy: Tablet Methotrexate Tablet Celecoxib Intervention2: Metronomic Therapy in addition to standard surgery and adjuvant radiation / chemoradiation: Tablet Methotrexate 1

Eligibility

Inclusion criteria

Inclusion criteria: 1.Biopsy proven SCC of oral cavity 2.AJCC Stage III and IV oral cancers excluding T1N1, T2N1 3.Operable lesion 4.ECOG 0/1

Exclusion criteria

Exclusion criteria: 1.Lesion mandating neoadjuvant chemotherapy in view of borderline resectability/unresectability 2.Prior treatment for cancer (surgery/RT/CT) 3.Pregnant women

Design outcomes

Primary

Measure	Time frame
Disease Free SurvivalTimepoint: 3 years	—

Secondary

Measure	Time frame
â?¢To assess the safety and toxicity profile of neoadjuvant oral metronomic chemotherapy â?¢To assess efficacy of neoadjuvant oral metronomic chemotherapy in terms of tumour response (WHO criteria) Timepoint: 3 years	—

Countries

India

Contacts

Public ContactMs Bharati Dalvi

Tata Memorial Centre

drpspai@gmail.com02224177185

Outcome results

None listed

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