Metformin With Neoadjuvant Chemoradiation to Improve Pathologic Responses in Rectal Cancer: An Internal Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Pathological Complete Response (pCR) rate
研究概览
简要总结
This study is a phase II, single arm, controlled, open label internal pilot.
详细描述
This internal pilot will be the first prospective study to assess the feasibility and efficacy of adding metformin in non-diabetic rectal patients who undergo standard of care neoadjuvant chemoradiation therapy (CRT). The translational aim of the study will inform on predictive factors (such as p53) and mechanism of action (hypoxia, proliferation). Metformin has been used for decades in patients with type 2 diabetes and has an extremely safe toxicity profile. With current interest in the use of metformin as a cancer therapeutic in non-diabetics, this study is expected to provide proof-of principle data for a larger study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Plan for care inclusive of:
- •i. standard of care neoadjuvant chemoradiation ii. planned total mesorectal excision (TME)
- •Histologically confirmed adenocarcinoma of the rectum
- •At least one of the following:
- •i. T3 or T4 lesions ii. T2 lesions ≤ 1 mm to the mesorectal fascia iii. Node positive rectal tumor
- •ECOG performance status of 0 or 1
- •Provide written informed consent
- •Female participants of childbearing potential agree to use adequate methods of contraception from the start of metformin administration until the start of CRT. Contraception will not be required to be continued during or after CRT as this treatment renders participants infertile. Clinically acceptable methods of birth control for this study include intrauterine devices (IUD), birth control pills, hormonal implants, injectable contraceptives, and using barrier methods such as condoms, vaginal diaphragm with spermicide, or sponge.
排除标准
- •Diagnosis of diabetes
- •Current use of metformin
- •Prior pelvic radiation
- •Life expectancy < 6 months.
- •Active infection
- •Creatinine > 1.5X ULN, within 1 month prior to baseline
- •AST, ALT > 2.5X ULN, within 1 month prior to baseline
- •Bilirubin > 1.5 ULN, within 1 month prior to baseline
- •Pregnant or breastfeeding women
研究组 & 干预措施
Metformin
Participants will self-administer 500mg metformin twice daily by mouth: 1) beginning 1 to 2 weeks prior to standard of care CRT, 2) during standard of care CRT and 3) until 30 days after the end of standard of care CRT.
干预措施: Metformin (Drug)
结局指标
主要结局
Pathological Complete Response (pCR) rate
时间窗: 1 year
The primary outcome is to evaluate the use of metformin to improve pathological complete response (pCR) rates in non-diabetic participants undergoing standard of care 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
- Tumor Proliferation Reduction(1 year)
- Tumor Hypoxia(1 year)