NCT03426904进行中（未招募）3 期
Neoadjuvant Chemotherapy for Non-metastatic Locally Advanced Colon Cancer: A Prospective Multicenter Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 708
- 试验地点
- 4
- 主要终点
- Relapse free survival after randomization
研究概览
简要总结
The main cause of recurrence after surgical treatment of colon cancer is distant metastasis. Neoadjuvant chemotherapy has potential benefits of improving the effectiveness of chemotherapy. Preoperative chemotherapy may eradicate microscopic metastatic cancer cells earlier than adjuvant chemotherapy, reduce cancer cell spillage during surgery, and lessen the invasiveness of surgical resection. This randomized multicenter phase III trial is assessing whether preoperative chemotherapy improves oncologic outcomes of patients with locally advanced colon cancer.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed colon adenocarcinoma (> 15 cm from the anal verge)
- •Radiologic T3/T4 and high risk features by CT scan
- •No metastasis on CT or PET(positron emission computed tomography)
- •Age ≥ 18 and ≤ 70 years
- •ECOG (Eastern Cooperative Oncology Group) performance status 0-1
- •No history of colorectal cancer within 5 years
- •No history of chemotherapy
- •Patients with childbearing potential should use effective contraception during the study and the following 6 months
- •Adequate bone marrow function : white blood cell count of 2 x 109/L or more with neutrophils of1.5 x 109/L or more, platelet count of 100 x 109/L or more, hemoglobin of 9 g/dL (5,6 mmol/l) or more
- •Adequate hepatobiliary function : total bilirubin of 0.4 mg/dl or less, ASAT (aspartate aminotransferase) and ALAT (alanine aminotransferase) of 2.5 x ULN (upper limits of normal) or less, Alkaline phosphatase of 1.5 x ULN or less
- •Adequate renal function : GFR (Glomerular Filtration Rate) > 50ml/min by Wright or Cockcroft formula
- •Signed written informed consent obtained prior to any study specific screening procedures
排除标准
- •Age > 70 years and < 18 years
- •Rectal cancer : 15 cm or less from the anal verge
- •Complicated colon cancer (complete obstruction, perforation, bleeding)
- •Metastatic colon cancer
- •Known hypersensitivity reaction to any of the components of study treatments
- •Inflammatory bowel disease
- •Hereditary nonpolyposis colorectal cancerHNPCC, familial Adenomatous Polyposis
- •Clinically relevant coronary artery disease or history of myocardial infarction in the last 6 months, high risk of uncontrolled arrhythmia
- •Galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
- •Pregnancy or breast-feeding period
- •Serious non-healing wound or bone fracture
- •Medical, geographical, sociological, psychological or legal conditions that would not permit the patient to complete the study or sign informed consent
- •Any significant disease which, in the investigator's opinion, would exclude the patient from the study
研究组 & 干预措施
Neoadjuvant FOLFOX
Experimental
4 cycles of FOLFOX (Folinic acid, fluorouracil and oxaliplatin) neoadjuvant followed by surgery and 8 cycles of FOLFOX
干预措施: Neoadjuvant FOLFOX (Drug)
Conventional adjuvant FOLFOX
Active Comparator
surgery followed by 12 cycles of FOLFOX
干预措施: Conventional adjuvant FOLFOX (Drug)
结局指标
主要结局
Relapse free survival after randomization
时间窗: 3 years after randomization
次要结局
- Overall survival(3 year after randomization)
- Length of hospital stay(60 days after surgery)
- Quality of life (EORTC QLQ-C30)(before treatment, before surgery, 3 months after surgery, 6 months after surgery, 1 year after surgery)
- Radiological assessment of response to neoadjuvant treatment(6 months after surgery)
- Incidence of completion of chemotherapy(1 year)
- Accuracy of CT staging(1 year)
- Pathological tumor stage(1 month after surgery)
- Pathological assessment of response to neoadjuvant treatment(1 months after surgery)
- Surgical complication(60 days after surgery)
- Quality of life (EORTC QLQ-C38)(before treatment, before surgery, 3 months after surgery, 6 months after surgery, 1 year after surgery)
- Toxicity of chemotherapy(1 year)
- Total cycles of perioperative chemotherapy(1 year)
研究者
Gyu-Seog Choi
Kyungpook National University Hospital
Kyungpook National University Hospital
研究点 (4)
Loading locations...
相似试验
已完成
不适用
Pattern of Cell Death Following Neoadjuvant Therapy for Metastatic Colon CancerMetastatic Colorectal CancerNCT00414492Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins100
Unknown
2 期
FOLFOXIRI for Neoadjuvant Treatment of High-risk Locally Advanced Colorectal CancerHigh-risk Locally Advanced Colorectal CancerNeoadjuvant ChemotherapyFOLFOXIRI RegimenNCT05018182West China Hospital69
进行中（未招募）
3 期
CONVERT: Neoadjuvant Chemotherapy Alone Versus Preoperative Chemoradiation for Locally Advanced Rectal Cancer PatientsRectal NeoplasmsNCT02288195Sun Yat-sen University663
尚未招募
Unknown
Efficacy and safety of postoperative adjuvant chemotherapy in colorectal cancer patients with sarcopenia: single-center retrospective observational studycolorectal cancerJPRN-UMIN000052063Shimane University Faculty of Medicine320
已完成
不适用
ocal recurrence after neoadjuvant chemotherapy among breast cancer-A multicenter retrospective cohort studybreast cancerJPRN-UMIN000041620Mie University Hospital200