NCT01035385Unknown3 期
Phase III Study to Compared Preoperative and Postoperative With FOFLOX4 Chemotherapy and Postoperative With FOFLOX4 Chemotherapy in Patients With Resectable Liver Metastasis From Colorectal Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 340
- 试验地点
- 1
- 主要终点
- progression free survival (PFS)
研究概览
简要总结
This study is a multicenter, open-label, randomized ,controlled phase III study to compare preoperative and postoperative with FOFLOX4 chemotherapy and postoperative with FOFLOX4 chemotherapy in patients with resectable liver metastasis from colorectal cancer.
详细描述
To investigate the three-year progression free survival (PFS) advantage of FOLFOX4 in the treatment of resectable metastatic colorectal 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Resectable liver metastasis from colorectal cancer(the distance from the tumor lower edge to anal more than 12cm),no visible extrahepatic metastatic tumors. Curable by resection, as determined by a surgeon and imaging physicians. The minimum of the liver metastases needs ≥2cm. Patients can be recruited if meet the conditions about:
- •Primary tumor had been removed of the metachronous liver metastasis patients and no residue from the eyes or microscope.
- •Primary tumor has been removed more than 1 month of the simultaneous liver metastasis patients.
- •Age of≥18 and ≤80
- •Signed written informed consent
排除标准
- •Peripheral neuropathy(CTC>1)
- •Had a neurological or mental disorders
- •Active infection
- •Allergy to Platinum-based and other drugs
- •Other acute diseases including infection, heart-disease(CHF, stable or unstable angina)
- •Pregnant or nursing patients
研究组 & 干预措施
FOFLOX4,resectable liver metastasis from CRC
Experimental
干预措施: FOFLOX4 (Drug)
结局指标
主要结局
progression free survival (PFS)
时间窗: 3 years
次要结局
- response rate, incidence of postoperative complications,pathological response rate,R0 resection rate, 5-year overall survival,duration of disease control(5 years)
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
3 期
Testing the Use of the Usual Chemotherapy Before and After Surgery for Removable Pancreatic CancerPancreatic Adenosquamous CarcinomaResectable Pancreatic AdenocarcinomaPancreatic CancerStage I Pancreatic Cancer AJCC v8Stage II Pancreatic Cancer AJCC v8Stage III Pancreatic Cancer AJCC v8NCT04340141Alliance for Clinical Trials in Oncology358
已完成
3 期
Efficacy of Neoadjuvant Folfirinox Regimen in Patients With Resectable Locally Advanced Rectal CancerCancer of the RectumNCT01804790UNICANCER461
已完成
3 期
CP-675,206 Versus Either Dacarbazine Or Temozolomide In Patients Without Prior TherapyMelanomaNCT00257205AstraZeneca655
招募中
3 期
Tislelizumab Combined With Chemotherapy Followed by Surgery Versus Up-front Surgery in Resectable Head and Neck Squamous Cell Carcinoma (REDUCTION-I)Head and Neck Squamous Cell CarcinomasNCT05582265Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University537
已完成
3 期
Comparison of Adjuvant Chemotherapy Regimens in Treating Stage II/III Rectal CancerRectal Mucinous AdenocarcinomaRectal Signet Ring Cell AdenocarcinomaRecurrent Rectal CarcinomaStage IIA Rectal Cancer AJCC v7Stage IIB Rectal Cancer AJCC v7Stage IIC Rectal Cancer AJCC v7Stage IIIA Rectal Cancer AJCC v7Stage IIIB Rectal Cancer AJCC v7Stage IIIC Rectal Cancer AJCC v7Stage IVA Rectal Cancer AJCC v7Stage IVB Rectal Cancer AJCC v7NCT00068692National Cancer Institute (NCI)225