A Multi-Institutional Phase II Trial Of Neoadjuvant Capecitabine (XELODA) And Oxaliplatin (ELOXATIN) For Resectable Colorectal Metastases In The Liver
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Rate of complete resection (R0 resection)
研究概览
简要总结
Drugs used in chemotherapy, such as capecitabine and oxaliplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Giving capecitabine and oxaliplatin before surgery may shrink the tumor so that it can be removed. Giving capecitabine and oxaliplatin after surgery may kill any remaining tumor cells. This phase II trial is studying how well capecitabine and oxaliplatin work when given before and after surgery in treating patients with resectable liver metastases that is secondary to colorectal cancer
详细描述
PRIMARY OBJECTIVES:
I. Determine the efficacy and toxicity of neoadjuvant and adjuvant capecitabine and oxaliplatin in patients with resectable liver metastases secondary to colorectal cancer who are undergoing surgery.
II. Determine the rates of R0 resection in patients treated with this regimen before surgery.
SECONDARY OBJECTIVES:
I. Determine the response rate in patients treated with this regimen. II. Determine the resectability in the subsets of patients defined as resectable preoperatively and treated with this regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed hepatic colorectal metastasis by percutaneous hepatic biopsy
- •Imaging evidence of liver metastasis by CT helical scan
- •Resectable disease, as determined by a surgeon with hepatic surgery expertise (at least 10 resections performed per year)
- •Resectable, defined as a sparing of 2 adjacent liver segments with adequate vascular inflow and outflow and hepatic remnant volume
- •Minor resections (less than a hemihepatectomy) or major resections (hemihepatectomy or extended hepatectomy) allowed
- •Bilobar resection allowed, including atypical resections
- •No evidence of extrahepatic disease by chest x-ray or CT scan of the chest, abdomen, and pelvis
- •Performance status - Zubrod 0-1
- •WBC at least 3,000/mm^3
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Hemoglobin at least 9.0 g/dL
- •Bilirubin no greater than 2 mg/dL
- •AST and ALT no greater than 300 IU/L
- •No preexisting chronic hepatic disease (e.g., chronic active hepatitis or cirrhosis) that would preclude surgical resection of metastases
- •Creatinine no greater than 1.5 mg/dL
- •Creatinine clearance 60 mL/min
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No cardiac arrhythmia
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No other malignancy within the past 5 years except completely resected nonmelanoma skin cancer or carcinoma in situ of the cervix
- •No preexisting grade 2 or greater peripheral neuropathy
- •No concurrent uncontrolled illness
- •No ongoing or active infection
- •No psychiatric illness or social situation that would preclude study compliance
- •No concurrent biologic therapy
- •No concurrent sargramostim (GM-CSF)
- •More than 6 months since prior adjuvant fluorouracil-based chemotherapy
- •No prior chemotherapy for liver metastasis
- •No prior oxaliplatin for colorectal cancer
- •No prior or concurrent hepatic artery infusion chemotherapy for metastatic disease
- •No prior or concurrent radiotherapy for metastatic disease
- •No prior or concurrent radiofrequency ablation for metastatic disease
- •No prior or concurrent cryotherapy/other ablative techniques for metastatic disease
- •No other concurrent investigational therapy
- •No concurrent oral anticoagulation
排除标准
- 未提供
研究组 & 干预措施
Treatment (oxaliplatin, capecitabine, and surgery)
Neoadjuvant chemotherapy: Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Surgery: Four to six weeks after the completion of chemotherapy, patients undergo surgical resection of the tumor.
Adjuvant chemotherapy: Patients with satisfactory response to therapy receive 4 additional courses of oxaliplatin and capecitabine after surgery.
干预措施: oxaliplatin (Drug)
Treatment (oxaliplatin, capecitabine, and surgery)
Neoadjuvant chemotherapy: Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Surgery: Four to six weeks after the completion of chemotherapy, patients undergo surgical resection of the tumor.
Adjuvant chemotherapy: Patients with satisfactory response to therapy receive 4 additional courses of oxaliplatin and capecitabine after surgery.
干预措施: capecitabine (Drug)
Treatment (oxaliplatin, capecitabine, and surgery)
Neoadjuvant chemotherapy: Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Surgery: Four to six weeks after the completion of chemotherapy, patients undergo surgical resection of the tumor.
Adjuvant chemotherapy: Patients with satisfactory response to therapy receive 4 additional courses of oxaliplatin and capecitabine after surgery.
干预措施: therapeutic conventional surgery (Procedure)
Treatment (oxaliplatin, capecitabine, and surgery)
Neoadjuvant chemotherapy: Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Surgery: Four to six weeks after the completion of chemotherapy, patients undergo surgical resection of the tumor.
Adjuvant chemotherapy: Patients with satisfactory response to therapy receive 4 additional courses of oxaliplatin and capecitabine after surgery.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Rate of complete resection (R0 resection)
时间窗: Up to 5 years
The design of Thall and Simon will be used.
次要结局
- Response rate assessed using RECIST criteria(Up to 5 years)
- Resectability in the subsets defined as resectable preoperatively(Up to 5 years)
- Improvement in survival associated with downstaging based on metastatic colorectal prognostic score(Up to 5 years)
- Disease-free survival(Up to 5 years)
- Overall survival(Up to 5 years)
- Positron emission tomography response rate(Up to 5 years)