JPRN-jRCTs011200001进行中（未招募）1 期
Multicenter Phase I/II Trial of Neoadjuvant Therapy for Locally Advanced Rectal Cancer by Chemoradiation Combined with Metformin - RC-COMET Study
Taketomi Akinobu0 个研究点目标入组 64 人开始时间: 2020年7月10日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 64
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 < 75age old（—）
- 性别
- All
入选标准
- •1. Rectal adenocarcinoma on biopsy of the primary tumor
- •2. Lower edge of the rectal cancer is less than 15 cm from the anal verge before chemoradiotherapy
- •3. Clinical T3-4NanyM0 before chemoradiotherapy
- •4. Resectable rectal cancer before chemoradiotherapy
- •5. Aged between 20 and 75 years
- •6. Eastern Cooperative Oncology Group Performance Status score of 0
- •7. Meeting each of the following parameters: white blood cell count: 3,000/mm3 or higher; neutrophil count: 2,000/mm3 or higher; hemoglobin level: 9.0 g/dL or higher; platelet count: 100,000/mm3 or higher; total bilirubin level: less than 2.0 mg/dL; and the ratio of aspartate aminotransferase and alanine aminotransferase: less than 3 times the normal upper value
- •8. Written informed consent
排除标准
- •1. Multiple primary cancers
- •2. Recurrent rectal cancer
- •3. History of chemoradiotherapy to the pelvis
- •4. Inflammatory bowel disease
- •5. Pulmonary fibrosis or interstitial pneumonia
- •6. Myocardial infarction or severe heart failure
- •7. Renal failure (creatinine level of >1.4 mg/dL in men and >1.3 mg/dL in women or a creatinine clearance rate of <60 mL/min)
- •8. Diabetes mellitus (glycated hemoglobin >6.5% or drug treatment)
- •9. Uncontrolled systemic infection
- •10. Pregnancy or lactation
- •11. Psychosis or mental symptoms that could make it difficult for patients to participate in the trial
- •12. Drug allergies to capecitabine and metformin
- •13. Patients not willing or able to follow the study protocol
- •14. Other inadequate conditions for the trial
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