Cyclophosphamide and Etoposide as a Promising Metronomic Therapy in Advanced Head and Neck Squamous Cell Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- The efficacy of Cyclophosphamide and Etoposide as metronomic therapy
研究概览
简要总结
The goal of this clinical trial is to learn if drugs as cyclophosphamide (C) and etoposide (E) work to treat advanced head and neck cancer in adults. It will also learn about the safety of both drugs. The main questions it aims to answer are:
Do drugs C and E work to treat advanced head and neck cancer, after failure on first line chemotherapy? What medical problems do participants have when taking drugs C and E? Researchers will compare drugs C and E in combination to a placebo (a look-alike substance that contains no drug) to see if these 2 drugs works to treat advanced head and neck cancer.
Participants will:
Take drug C every 3 weeks and drug E every 4 weeks or a placebo every week for 6 months.
Visit the clinic once every 3 weeks for checkups and tests. Keep a diary of their symptoms.
详细描述
This clinical trial aims to evaluate the potential efficacy of cyclophosphamide and etoposide as metronomic therapy in recurrent/resistant and/or metastatic head and neck squamous cell carcinoma adults after failure on first line chemotherapy, or intolerant to further aggressive chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult participants, age = or > 18 years
- •Participants with recurrent head and neck squamous cell carcinoma after failure on first line chemotherapy.
- •Participants with advanced progressed, resistant, metastatic head and neck squamous cell carcinoma.
排除标准
- •Adjuvant and Neoadjuvant head and neck squamous cell carcinoma patients.
研究组 & 干预措施
Cyclophosphamide and Etoposide in combination
Participants in intervention arm will receive cyclophosphamide IV 400 mg/m2 every 3 weeks and etoposide 100 mg/m2 daily for 3 days every 4 weeks, for total 6 months.
干预措施: Cyclophosphamide and Etoposide in combination (Drug)
Methotrexate
Participants in control arm will receive weekly Methotrexate 50 mg for total 6 months.
干预措施: Methotrexate (Drug)
结局指标
主要结局
The efficacy of Cyclophosphamide and Etoposide as metronomic therapy
时间窗: From first day of the study to the end of treatment at 6 months.
The efficacy of Cyclophosphamide and Etoposide as metronomic therapy in improving disease response. Tumor size (tumor dimensions: length, width, height) as measured by Computed Tomography, illustrating whether the disease is progressed, regressed or stationary. In addition to serum LDH level. Both will be assessed every 3 cycles.
次要结局
- Assessment of clinical symptoms(From the first day of the study till the end of treatment at 6 months)
- Progression free survival(From first day of the study till the end of study at 6 months)
- Overall survival(From the first day of study till the end of study at 8 months)