Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx
Conditions
Interventions
Intervention1: NIL: NIL
Control Intervention1: NIL: NIL
Sponsors
Jawaharlal Nehru Medical College
Eligibility
Inclusion criteria
Inclusion criteria: Histopathologically proven squamous cell carcinoma of head & neck cancer patients. Patient is a candidate for concurrent Chemoradiation. Unsuitable for cisplatin due to Calculated Creatinine clearance less than 50 ml per min or Hearing loss or tinnitus grade greater than 3 or Allergy to agents that contain platinum.
Exclusion criteria
Exclusion criteria: History of previous malignancy. Previous irradiation. Distant metastasis. Presence of immunodeficiency syndromes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Estimate the adverse event profile and compliance of docetaxel with radiation in cisplatin-ineligible patientsTimepoint: 7 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Assess 1yr Disease Free Survival Timepoint: 1 year;Assess 1yr Overall Survival Timepoint: 1 year;Estimate the compliance of patients with Radiation- 90% completion rate and Concurrent Chemotherapy (Docetaxel)- 5 or more cycles Timepoint: 7 weeks;Estimate the rate of any grade adverse eventTimepoint: 7 weeks;Estimate the rate of grade 3 or above adverse events Timepoint: 7 weeks;Evaluate the number of Hospital admissions during the course of treatment Timepoint: 7 weeks;Evaluate the percentage of Interruptions during the course of treatmentTimepoint: 7 weeks | — |
Countries
India
Contacts
Public ContactHimanshi Kaushik
Jawaharlal Nehru Medical College, Sawangi(Meghe), Wardha
Outcome results
None listed