KCT0004874招募中未知
A Multicenter, Randomized Controlled Trial of Preoperative Sequential Short-course Radiation Therapy and Oxaliplatin-based Consolidation Chemotherapy for Locally Advanced Rectal Cancer
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 364
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 75(Year)（—）
- 性别
- All
入选标准
- •1. A male/female adult between ages 20 and 75
- •2. Race : Asian
- •3. Eastern Cooperative Oncology Group performance score 0-2
- •4. Pathologically confirmed rectal cancer (rectal cancer located 10 cm or low from the anal verge in pelvis magnetic resonance imaging (MRI)]
- •5. Histologic type: adenocarcinoma, mucinous carcinoma, and signet ring cell carcinoma
- •6. Locally advanced rectal cancer with one or more of the following factors based on pelvis MRI: cTanyN1-2, cT3-4N0, or presence of extramural vascular invasion
- •7. It is not an exclusion criterion if the pelvis MRI shows findings such as pelvic lymph node metastasis, anal sphincter invasion, MRF (+), and T4b. This will depend on the researcher’s discretion. MRI findings such as pelvic lymph node metastasis, anal sphincter invasion, and T4b are not included in the exclusion criteria, which cases will be enrolled by the researcher’s discretion.
- •8. Patients with appropriate organ (bone marrow, kidney, and liver) function Normal liver function (direct bilirubin< 0.4 mg/dL)
- •Normal renal function (glomerular filtration rate > 50 mL/min by Wright or Cockroft formula)
- •Normal bone marrow function (whilte blood cell > 3.0 × 109/L, platelet>100×109/l)
- •9. A person who understands the study and is willing to provide informed consent
排除标准
- •1. Colon cancer or rectal cancer located above more than 10 cm from the anal verge
- •2. Stage I rectal cancer (clinical stage cT1-2N0)
- •3. Clinically or pathologically diagnosed distant metastasis (cTanyNanyM1)
- •4. Familial adenomatous polyposis
- •5. Hereditary nonpolyposis colorectal cancer
- •6. History of chemotherapy or radiotherapy within 6 months
- •7. History of colorectal cancer or other type of malignancy within 5 years
- •8. Currently under treatment or malignant tumors (except for cured nonmelanoma skin cancer or in situ cervical cancer)
- •9. Comorbidities that render it difficult to undergo chemotherapy or radiotherapy
- •10. Bone marrow suppression with neutrophil count < 2 x 109/L and/or platelet count < 100 x 109/L prior to the first chemotherapy
- •administration cycle
- •11. Peripheral sensory neuropathy with functional impairment prior to the first administration cycle (grade 2 or higher)
- •12. Severe renal dysfunction (GFR =30ml/min by Wright or Cockroft formula)
- •13. Severe hepatic dysfunction
- •14. Genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose- galactose malabsorption
- •15. Patients receiving tegafur, gimeracil, and oteracil complex and those within 7 days of discontinuation
- •16. Taking sorivudine or brivudine
- •18. Significant heart disease or myocardial infarction within the past 6 months
- •18. Hereditary diseases or history of coagulopathy
- •19. Central nervous system disorders with disability or mental disorders
- •20. Pregnant or lactating women
- •21. Currently participating in other clinical trials or receiving research medication
- •22. Unhealed wounds, fractures, peptic ulcer, abscesses in the abdominal cavity
- •23. Active gastrointestinal bleeding
- •24. Active infection requiring intravenous antibiotics
- •25. Emergency surgery
- •26. History of hypersensitivity reaction to drugs in the study protocol
- •27. Dihydropyridine dehydrogenase deficiency
- •28. Not willing to participate
研究者
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