Tumor Mutation Status Will Predict Metabolic Response to Metformin in Non Small Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- RECIST and PERCIST Tumor Response
研究概览
简要总结
The goal of this clinical research study is to learn if giving metformin in combination with radiation therapy is more effective than radiation therapy alone. In this study, participants will receive either metformin or a placebo. A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.
This is an investigational study. Metformin is FDA approved for the treatment of diabetes. Its use in this study to be given with radiation therapy to treat lung cancer is investigational. The study doctor can explain how the study drug is designed to work.
Up to 70 participants will be enrolled in this study. All will take part at MD Anderson.
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
- Double (Participant, Investigator)
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
- •Patients with pathologic diagnosis of lung NSCLC or squamous cell carcinoma.
- •Patients are to be treated with hypofractionated RT.
- •Patient is not a surgical candidate due to medical comorbidities determined by a thoracic surgeon or patient refusal
- •Patient plans to receive treatment at MD Anderson
- •Patients must sign informed consent
- •Patient must have adequate renal function within 30 days prior to registration, defined as serum creatinine within normal institutional limits or creatinine clearance at least 60 ml/min
排除标准
- •Patient has: random glucose >200 mg/dl or is taking an oral hypoglycemic agent or insulin at the time of study entry
- •Patient has a history of lactic acidosis, chronic kidney disease or a creatinine >/= 1.2 mg/dl
- •Women who are pregnant or breast feeding, as treatment involves unforeseeable risks to the participant, embryo, fetus, or nursing infant
- •Patients with history of allergic reaction to metformin
研究组 & 干预措施
Stereotactic body Radiotherapy (SBRT) + Metformin
Participants randomized to Metformin treatment receive Metformin for 3 weeks prior to SBRT treatment and for 1 week during SBRT treatment. Metformin administered at a dose of 2000 mg by mouth in divided dose daily (500 mg am, 1000 mg noon, 500 mg pm). To reduce GI toxicity, participants start Metformin at 1000 mg daily in a divided dose (500mg am, 500 mg pm) for 1 week. SBRTdelivered per standard of care practice.
干预措施: Metformin (Drug)
Stereotactic body Radiotherapy (SBRT) + Metformin
Participants randomized to Metformin treatment receive Metformin for 3 weeks prior to SBRT treatment and for 1 week during SBRT treatment. Metformin administered at a dose of 2000 mg by mouth in divided dose daily (500 mg am, 1000 mg noon, 500 mg pm). To reduce GI toxicity, participants start Metformin at 1000 mg daily in a divided dose (500mg am, 500 mg pm) for 1 week. SBRTdelivered per standard of care practice.
干预措施: Stereotactic body Radiotherapy (SBRT) (Radiation)
Stereotactic Body Radiotherapy (SBRT) + Placebo
Participants randomized to placebo treatment 3 weeks prior to SBRT treatment and for 1 week during SBRT treatment. Placebo administered by mouth three times a day. SBRT delivered per standard of care practice.
干预措施: Placebo (Other)
Stereotactic Body Radiotherapy (SBRT) + Placebo
Participants randomized to placebo treatment 3 weeks prior to SBRT treatment and for 1 week during SBRT treatment. Placebo administered by mouth three times a day. SBRT delivered per standard of care practice.
干预措施: Stereotactic body Radiotherapy (SBRT) (Radiation)
结局指标
主要结局
RECIST and PERCIST Tumor Response
时间窗: From baseline (prior to metformin start) to Post-Radiotherapy (RT) Treatment, assessed up to 6 months
The primary objective is the effect of metformin on response in NSCLC patients treated with hypofractionated RT. All patients will receive FDG-PET/CT scan at baseline (prior to metformin start), prior to RT and at 6 months (+/- 30 days) following RT. PET/CT imaging using \[18F\]-2-fluoro-2-deoxyglucose positron emission tomography (18F-FDG), using a standard approved radiopharmaceutical dose and administration selected by the nuclear medicine physician (120 min). Response will be determined at 6 months post-treatment via relative change from pre-treatment tumor by Response Evaluation Criteria in Solid Tumor (RECIST) by complete response (CR), partial response (PR) and stable disease (SD) and PET Response Criteria in Solid Tumors (PERCIST) by stable metabolic disease (SMD), progressive metabolic disease (PMD) and complete metabolic response(CMR).
次要结局
未报告次要终点