CTRI/2026/01/101914尚未招募2/3 期
A Prospective Comparative Study Evaluating Efficacy, Compliance and Safety of Weekly Intravenous Methotrexate with or without Oral Gefitinib in Advanced and Metastatic Carcinoma Oral Cavity Patients, Inoperable and Ineligible for Intensive Chemotherapy.
Shyam Sundar Adhikary1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2026年2月9日最近更新:
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Objective response rates (ORR)
研究概览
简要总结
| Oral cavity squamous cell carcinoma is a prevalent malignancy with a poor prognosis in advanced stages. Traditional chemotherapy regimens, such as cisplatin, are often not feasible for patients with compromised performance status or comorbidities. Effective, affordable, and well-tolerated palliative treatments are therefore essential to improve overall survival and quality of life. Metronomic therapy is one of the proven methods for treatment of terminally ill patients with malignancy, who are otherwise not fit for chemotherapy. Methotrexate, a folate antagonist, has been utilized in low-dose regimens for palliation. Approximately 80-90% of head and neck squamous cell carcinoma exhibit increased expression or contain genetic variations in EGFR. Hence Gefitinib, and EGFR inhibitor, has potential in enhancing treatment efficacy. Combining these agents may offer improved outcomes without the need for intensive chemotherapy. |
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Day(s) 至 80.00 Day(s)（—）
- 性别
- All
入选标准
- •1.Histologically confirmed metastatic or advanced oral cavity squamous cell carcinoma 2.Age equal to or more than 18 years 3.ECOG performance status 3 or higher 4.Patients might or might not have received local radiotherapy 5.Ineligibility for intensive chemotherapy due to comorbidities or poor performance status 6.Written informed consent 7.Blood parameters within normal limits.
排除标准
- •1.Prior treatment with EGFR inhibitors 2.Active interstitial lung disease 3.Several renal or hepatic dysfunction 4.Pregnancy or breast feeding.
结局指标
主要结局
Objective response rates (ORR)
时间窗: 3 months, 6 months, 9 months
次要结局
- 1.Treatment compliance(2.Toxicity profiles)
研究者
Shyam Sundar Adhikary
Bankura Sammilani Medical College and Hospital
研究点 (1)
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