Real World Data Collection of Nimotuzumab in Cisplatin ineligible Locally Advanced Head & Neck Cancer
Not Applicable
- Conditions
- Health Condition 1: C109- Malignant neoplasm of oropharynx,unspecified
- Registration Number
- CTRI/2023/07/055558
- Lead Sponsor
- Biocon Biologics Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall response rateTimepoint: 6 months
- Secondary Outcome Measures
Name Time Method Disease control rateTimepoint: 12 months;FACT-HN <br/ ><br>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