Health Condition 1: C069- Malignant neoplasm of mouth, unspecified
Conditions
Interventions
Intervention1: Radiation therapy: To apply hypofractionated (52.5 Gy/15#,5days/week over 3 weeks) by Cobalt60 machine without giving prior or concurrent chemotherapy. Spine shielding will be done at 9
Sponsors
Dr Kazi Nazmul Huda
Eligibility
Inclusion criteria
Inclusion criteria: 1. Voluntarily giving written consent for the study 2. Diagnosed with oral cavity squamous cell carcinoma (any histologic type) by histopathlogical confirmation 3.AJCC 8th TNM staging: T4a/T4b any N M0 any T N3 M0 4.Adult patients (age limit upto 70 years) 5.Good general condition 6.Performance status :ECOG upto 2 7. Normal haematological parameter Hb: more than 10 gm/dl Absolute Neutrophil count : more than 1500/cmm Platelet count :more than 1 Lakh/cmm 8. Normal biochemical parameter Liver enzymes(ALT/AST): less than 3x Upper normal limit Estimated creatinine clearance : more than 50 ml/min 9. Willing to follow up.
Exclusion criteria
Exclusion criteria: 1. Any head & neck carcinoma other than oral cavity 2. Histological variety othr than squamous cell carcinoma 3. Any uncontrolled comorbid condition 4. Early stage / feasible for radical surgery 5. Metastatic carcinoma 6. No caregiver 7. Prior treatment with chemotherapy, radiotherapy, surgery with radical intent 8. Any second primary or other malignancy within the last 5 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the response using Response Assessment Criteria In Solid Tumour1.1 (RECIST 1.1)Timepoint: at 6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess the highest grade of toxicity during & 6 weeks after treatment using CTCAE V.5 2. To assess QOL(Quality of life) using EORTC QLQ C-30 questionnaire Timepoint: During Radiotherapy, at 6 weeks of completion of Radiotherapy | — |
Countries
India
Contacts
Public ContactDr Kazi Nazmul Huda
Outcome results
None listed