Health Condition 1: C109- Malignant neoplasm of oropharynx,unspecified
Conditions
Interventions
Intervention1: NIL: NIL
Sponsors
Biocon Biologics Limited
Eligibility
Inclusion criteria
Inclusion criteria: Histologically and cytologically confirmed diagnosis of locally advanced head and neck squamous cell carcinoma (LAHNSCC) Adults of either sex, between 18 years or above who have been prescribed Nimotuzumab in routine clinical practice Patients with Renal dysfunction, Hearing impairment, Neuropathy, or patients unfit for cisplatin therapy as per physician’s discretion Patients with Marrow, Respiratory, Cardiovascular, and Hepatic dysfunctions
Exclusion criteria
Exclusion criteria: Patients will not be eligible if known or suspected hypersensitivity to compounds with similarity to Nimotuzumab or Pregnant or lactating women or Patients who decline consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rateTimepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rateTimepoint: 12 months;FACT-HN Timepoint: 0 months & 6 months;Frequency, incidence, & severity of adverse events (AEs)Timepoint: 6 & 12 months;Impact of assessment of personalized cancer care on quality of life using FACT-HN ScoreTimepoint: 6 months;Overall response rateTimepoint: 12 months;Overall SurvivalTimepoint: 12 months;Progression-free survivalTimepoint: 12 months | — |
Countries
India
Contacts
Public ContactDr Amit Yashwant Jadhav
Biocon Biologics Limited
Outcome results
None listed