PHASE III STUDY OF HEPATIC ARTERY FLOXURIDINE (FUDR), LEUCOVORIN (LV), AND DEXAMETHASONE (DEX) VERSUS SYSTEMIC 5-FLUOROURACIL (5-FU) AND LEUCOVORIN (LV) AS TREATMENT FOR HEPATIC METASTASES FROM COLORECTAL CANCER
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 135
- 试验地点
- 14
- 主要终点
- Overall survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known which chemotherapy regimen is more effective for metastatic colorectal cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of intrahepatic floxuridine, leucovorin, and dexamethasone with that of systemic fluorouracil and leucovorin in treating patients who have unresectable liver metastases from colorectal cancer.
详细描述
OBJECTIVES:
- Compare the efficacy, toxicity, and cost of hepatic artery infusion of floxuridine, leucovorin calcium (CF), and dexamethasone vs IV fluorouracil and IV CF after resection of primary disease in patients with hepatic metastases secondary to colorectal cancer.
- Compare the quality of life of patients treated with these regimens.
- Measure the level of thymidylate synthase present in liver metastases, and correlate these levels with objective response and survival in patients treated with these regimens.
- Assess the p53 mutations, and correlate findings with objective response and survival in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, percentage of liver involvement on CT scan or MRI (less than 30% vs 30% to under 70%), prior chemotherapy (none vs adjuvant chemotherapy comprising fluorouracil (5-FU) and leucovorin calcium (CF) or 5-FU, CF, and levamisole (LEV) completed at least 1 year before study vs adjuvant chemotherapy comprising 5-FU with or without LEV completed at least 6 months before study), and synchronous disease (yes vs no). Patients are randomized to 1 of 2 treatment arms.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm I - laparotomy + conventional surgery + chemotherapy
Patients undergo laparotomy for placement of a hepatic artery catheter and then subcutaneous placement of a hepatic artery infusion pump. Patients with unresected primary disease also undergo resection at the time of catheter and pump placement. Beginning within 1-2 weeks after surgery, patients receive floxuridine, dexamethasone, and leucovorin calcium (CF) via continuous hepatic artery infusion on days 1-14. Treatment for patients continues every 4 weeks in the absence of disease progression or unacceptable toxicity.
Quality of life and medical resource utilization are assessed at baseline, every 3 months for 1 year, and then at 18 months.
Patients are followed every 3 months.
干预措施: dexamethasone (Drug)
Arm I - laparotomy + conventional surgery + chemotherapy
Patients undergo laparotomy for placement of a hepatic artery catheter and then subcutaneous placement of a hepatic artery infusion pump. Patients with unresected primary disease also undergo resection at the time of catheter and pump placement. Beginning within 1-2 weeks after surgery, patients receive floxuridine, dexamethasone, and leucovorin calcium (CF) via continuous hepatic artery infusion on days 1-14. Treatment for patients continues every 4 weeks in the absence of disease progression or unacceptable toxicity.
Quality of life and medical resource utilization are assessed at baseline, every 3 months for 1 year, and then at 18 months.
Patients are followed every 3 months.
干预措施: floxuridine (Drug)
Arm I - laparotomy + conventional surgery + chemotherapy
Patients undergo laparotomy for placement of a hepatic artery catheter and then subcutaneous placement of a hepatic artery infusion pump. Patients with unresected primary disease also undergo resection at the time of catheter and pump placement. Beginning within 1-2 weeks after surgery, patients receive floxuridine, dexamethasone, and leucovorin calcium (CF) via continuous hepatic artery infusion on days 1-14. Treatment for patients continues every 4 weeks in the absence of disease progression or unacceptable toxicity.
Quality of life and medical resource utilization are assessed at baseline, every 3 months for 1 year, and then at 18 months.
Patients are followed every 3 months.
干预措施: leucovorin calcium (Drug)
Arm I - laparotomy + conventional surgery + chemotherapy
Patients undergo laparotomy for placement of a hepatic artery catheter and then subcutaneous placement of a hepatic artery infusion pump. Patients with unresected primary disease also undergo resection at the time of catheter and pump placement. Beginning within 1-2 weeks after surgery, patients receive floxuridine, dexamethasone, and leucovorin calcium (CF) via continuous hepatic artery infusion on days 1-14. Treatment for patients continues every 4 weeks in the absence of disease progression or unacceptable toxicity.
Quality of life and medical resource utilization are assessed at baseline, every 3 months for 1 year, and then at 18 months.
Patients are followed every 3 months.
干预措施: laparotomy (Procedure)
Arm I - laparotomy + conventional surgery + chemotherapy
Patients undergo laparotomy for placement of a hepatic artery catheter and then subcutaneous placement of a hepatic artery infusion pump. Patients with unresected primary disease also undergo resection at the time of catheter and pump placement. Beginning within 1-2 weeks after surgery, patients receive floxuridine, dexamethasone, and leucovorin calcium (CF) via continuous hepatic artery infusion on days 1-14. Treatment for patients continues every 4 weeks in the absence of disease progression or unacceptable toxicity.
Quality of life and medical resource utilization are assessed at baseline, every 3 months for 1 year, and then at 18 months.
Patients are followed every 3 months.
干预措施: conventional surgery (Procedure)
Arm II - conventional surgery + chemotherapy
Patients receive CF IV and fluorouracil IV on days 1-5. Patients with unresected primary disease undergo resection within 3-4 weeks before initiation of chemotherapy.
Treatment for patients continues every 4 weeks in the absence of disease progression or unacceptable toxicity.
Quality of life and medical resource utilization are assessed at baseline, every 3 months for 1 year, and then at 18 months.
Patients are followed every 3 months.
干预措施: fluorouracil (Drug)
Arm II - conventional surgery + chemotherapy
Patients receive CF IV and fluorouracil IV on days 1-5. Patients with unresected primary disease undergo resection within 3-4 weeks before initiation of chemotherapy.
Treatment for patients continues every 4 weeks in the absence of disease progression or unacceptable toxicity.
Quality of life and medical resource utilization are assessed at baseline, every 3 months for 1 year, and then at 18 months.
Patients are followed every 3 months.
干预措施: leucovorin calcium (Drug)
Arm II - conventional surgery + chemotherapy
Patients receive CF IV and fluorouracil IV on days 1-5. Patients with unresected primary disease undergo resection within 3-4 weeks before initiation of chemotherapy.
Treatment for patients continues every 4 weeks in the absence of disease progression or unacceptable toxicity.
Quality of life and medical resource utilization are assessed at baseline, every 3 months for 1 year, and then at 18 months.
Patients are followed every 3 months.
干预措施: conventional surgery (Procedure)
结局指标
主要结局
Overall survival
时间窗: Up to 5 years
Time to progression
时间窗: Up to 5 years
次要结局
未报告次要终点