Health Condition 1: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx
Conditions
Interventions
Intervention1: Group A : patients receiving weekly paclitaxel with concurrent radiation.: 40 mg/m2 of inj paclitaxel in 500 ml of NS over 2 hours via codon set after premedication weekly
Control Inter
Sponsors
Jawaharlal Institute of Postgraduate Medical Education and Research JIPMER Pondicherry
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria : 1)Patients of biopsy proven squamous cell carcinoma of oral cavity, oropharyngeal and hypo-pharyngeal cancer planned for radical radiation with concurrent chemotherapy after multidisciplinary tumor clinic discussion.2)Age > 18 yrs 3) ECOG performance status 0-2. 4) Adequate renal function (creatinine clearance >60 ml/min ) 5) Normal liver function tests.
Exclusion criteria
Exclusion criteria: Exclusion criteria : 1)Age > 65yrs 2)Patients with distant metastasis. 3)Patients with uncontrolled hypertension, diabetes mellitus, ischemic heart disease. 4)H/o previous oncological surgery for the same condition. 5)H/o previous irradiation to the same site.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoint : Proportion of treatment completion in all eligible patients. Weekly arm Paclitaxel : 5 to 7 cycles chemo during RT period. Weekly arm Cisplatin : 5 to 7 cycles chemo during RT period.Timepoint: From start of radiation treatment till completion of full course of radiation ( approximately 6-7 weeks for each patient ) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoint Acute toxicities during the course of treatment assessed weekly using CTCAE v5.0Timepoint: During full course of concurrent chemoradiation , till 1 month after completion of treatment | — |
Countries
India
Contacts
Public ContactDr Sourav Biswas
Jawaharlal Institute of Postgraduate Medical Education and Research
Outcome results
None listed