Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx
Conditions
Interventions
Intervention1: Palliative hypofractionated radiotherapy with chemotherapy in locally advanced head and neck squamous cell carcinoma: Patients in the interventional arm will receive Inj.Docetaxel 50mg/
Sponsors
Mruthulagi S P
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age: above 18 years less than 80 yrs. 2. Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, larynx and hypopharynx. 3. Stage: cT4a, T4b, N1-3, M0, and ECOG Performance status: 2-3, planned for palliative radiation. 4. Patient with normal renal, haematological and hepatic parameters.
Exclusion criteria
Exclusion criteria: 1. Any patient with Stage: cT1-3, N1,2a,b,c, M0, ECOG PS: 0,1, squamous cell carcinoma of the head and neck planned for curative intent treatment- definitive or adjuvant radiation 2. Cancers arising from the salivary gland, nasal cavity, paranasal sinuses and nasopharynx 3.Abnormal renal function (creatinine clearance less than 45 ml/min), haematological parameters (grade 3-4 neutropenia and thrombocytopenia ) and liver function (serum Alkaline Phosphatase more than 6 times the normal upper limit, serum AST +/or ALT more than 3.5 times the normal upper limit) 4.Cardiovascular abnormalities which include prior history of myocardial infarction, angina, dysrhythmias, Coronary Artery Disease(CAD), cardiac failure. 5. Previous history of hypersensitivity to Docetaxel or platinum-containing compounds 6. Recurrent tumors 7. Uncontrolled co-morbidities 8. Non squamous pathology. 9. Prior history of radiation 10. Pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To compare the progression-free survival (PFS) in both arms.Timepoint: Expected time to follow up - 14 months. Events for PFS will include disease progression, relapse (locoregional or distant), the development of a second primary, or death from any cause. PFS will be defined as the time from random assignment to attainment of an event for PFS | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To compare the overall response of the tumour in both arms assessed by contrast-enhanced CT of the head and neck using RECIST 1.1 criteriaTimepoint: 3 months post-treatment;2. To compare the locoregional control (LRC) in both arms assessed by contrast-enhanced CT of the head and neck, using RECIST 1.1 criteriaTimepoint: 6 months and 1 year post-treatment;4. To compare the quality of life in both arms using EORTC QOL 30 and EORTC QOL 35 questionnaire version 3.0Timepoint: 6 months post radiation.;5. To compare the proportion of patients developing acute and late side effects of radiation using acute and late RTOG toxicity scoring criteria and CTCAE version 5.0 toxicity criteria.Timepoint: Weekly during the course of radiation and 3 months post treatment;6. To assess the proportion of patients developing chemotherapy toxicity using CTCAE version 5.0 toxicity criteria.Timepoint: Weekly during the course of chemotherapy.;To compare the overall survival (OS) in both arms.Timepoint: Events for OS will include death from any cause. OS will be measured from the time of random assignment to death from any cause. | — |
Countries
India
Contacts
Public ContactShyama Prem
Jawaharlal Institute of Post Graduate Medical Education and Research, JIPMER, Puducherry
Outcome results
None listed