Metformin Enhances Pathological Complete Response in Non-Diabetic Rectal Cancer Patients Undergoing Neoadjuvant Chemoradiotherapy: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 85
- 试验地点
- 2
- 主要终点
- Pathological Complete Response (pCR) rate
研究概览
简要总结
Design: Prospective, randomized controlled clinical trial Setting: at Minia University Hospital and Minia Oncology Institute. Condition: Colorectal cancer.
To be eligible for participation, patients must meet the following criteria:
- Histologically confirmed diagnosis of rectal adenocarcinoma.
- Age starting from 18 and older.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Adequate organ function (renal, hepatic, and hematological)
- Signed informed consent.
Patients will be randomized into two groups:
Group A: Patients will receive standard chemoradiotherapy(CRT).
Group B: Patients will self-administer 1000mg of metformin twice daily by mouth:
- beginning 1-2 weeks before standard CRT.
- during standard CRT.
- until 30 days after the end of standard CRT.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed diagnosis of rectal adenocarcinoma.
- •Age starting from 18 and older.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •Adequate organ function (renal, hepatic, and hematological)
- •Signed informed consent.
排除标准
- •Metastatic disease.
- •Contraindications to metformin.
- •Significant comorbidities or medical conditions that may interfere with study participation. (D.M, PCO,..)
- •eGFR less than 30 mL/min.
- •Pregnant or breastfeeding women.
研究组 & 干预措施
Group B (Metformin)
Patients will self-administer 1000mg of metformin twice daily by mouth:
- beginning 1-2 weeks before standard CRT.
- during standard CRT.
- until 30 days after the end of standard CRT.
干预措施: Metformin (Drug)
结局指标
主要结局
Pathological Complete Response (pCR) rate
时间窗: 6 months
The Main outcome is to assess the use of metformin to improve pathological complete response (pCR) rates among non-diabetic participants undergoing standard neoadjuvant CRT for rectal cancer. The primary outcome will be measured by the pathological complete response rate after completion of the study treatment.
次要结局
未报告次要终点
研究者
Omar Mohamed Awad
Teaching Assistant
Minia University