An Observational Real World Data Collection to Assess Effectiveness & Safety of Nimotuzumab in Cisplatin ineligible Locally Advanced Head and Neck Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 8
- 主要终点
- Overall response rate
研究概览
简要总结
Many patients may be ineligible for cisplatin due to age or medical comorbidities, develop intolerance necessitating treatment breaks, or survive with chronic adverse effects. Considering the increased rates of significant adverse effects of concurrent chemotherapy and radiation therapy (CRT), the MACH-NC study found a decreasing benefit of systemic therapy with increasing age. Efficacy and tolerability of nimotuzumab plus Chemotherapy (Carboplatin/docetaxel/5FU) plus RT or Nimotuzumab plus RT in patients with LAHNSCC who are ineligible for cisplatin treatment have limited evidence in Indian settings. So, we aimed this real-world observational data collection, prospectively, to observe clinical outcomes and safety of "Nimotuzumab plus RT, or Nimotuzumab plus Chemotherapy (Carboplatin/docetaxel/5FU) plus RT" in patients with LAHNSCC who are ineligible for cisplatin treatment. Also, the impact of personalized cancer care on patients’ quality of life will be evaluated.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Overall response rate
时间窗: 6 months
次要结局
- Overall response rate(12 months)
- Overall Survival(12 months)
- Frequency, incidence, & severity of adverse events (AEs)(6 & 12 months)
- FACT-HN
- Disease control rate(12 months)
- Progression-free survival(12 months)
- Impact of assessment of personalized cancer care on quality of life using FACT-HN Score(6 months)