Health Condition 1: C069- Malignant neoplasm of mouth, unspecified Health Condition 2: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx
Conditions
Interventions
Intervention1: 3 weekly chemoradiation: For patients in 3 weekly chemoradiation arm, concurrent Cisplatin will be given once every 3 weeks at 100mg/sq. meter of body surafce area. For patients with im
Sponsors
institute of Medical Sciences Banaras Hindu University
Eligibility
Inclusion criteria
Inclusion criteria: 1.Post operative oral cavity carcinoma (AJCC Pathological group staging I-IVa) 2. Squamous cell carcinoma histology 3. High risk features like positive resection margin and/or Extracapsular extension 4. ECOG 0-1 5. Adequate hematologic, renal and hepatic function 6. Adequate creatinine clearance
Exclusion criteria
Exclusion criteria: 1. Any synchronous or metachronous malignancy 2. Patients who received neo-adjuvant chemotherapy 3. Previous history of chemotherapy and/or radiotherapy for any other malignancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| loco-regional controlTimepoint: 3 months 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall SurvivalTimepoint: 3 months 6 months;Disease Free SurvivalTimepoint: 3 months 6 months;Acute ToxicityTimepoint: Weekly during chemoradiation, upto 3 months of completion of chemoradiation;Late toxicityTimepoint: 3 months 6 months;Quality of Life AssessmentTimepoint: Before start of Chemoradiation, After completion of Chemoradiation | — |
Countries
India
Contacts
Public ContactProf Dr Himanshu Mishra
Institute of Medical Sciences, BHU
Outcome results
None listed