A Multi-center Randomized Controlled Trial: Intraportal Chemotherapy Combined With Adjuvant Chemotherapy (mFOLFOX6) for Stage II and III Colon Cancer
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- disease-free survival
研究概览
简要总结
To investigate whether intraoperative intraportal chemotherapy combined with adjuvant chemotherapy as treatment could improve disease-free survival (DFS) in patients with curative colorectal cancer resection compared with adjuvant chemotherapy alone.
This is a prospective, blind (doctors who done outcome measures were masked), multi-center, 2-arm randomized controlled trial.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 and ≤ 75 years;
- •Primary tumor has undergone histologically confirmed colon adenocarcinoma; Colon cancer was defined by the presence of the inferior pole of the tumor above the peritoneal reflection (at least 15 cm from the anal margin).
- •Together with clinical or radiological evidence of Stage II (T3-4, N0, M0) or Stage III (T1-4, N1-2, M0) disease (according to the 2007 revision of the International Union Against Cancer TNM staging system)
- •Performance status (ECOG) 0~1
- •Adequate hematological function: Neutrophils≥1.5 x109/l and platelet count≥100 x109/l; Hb ≥9g/dl (within 1 week prior to randomization)
- •Adequate hepatic and renal function: Serum bilirubin≤1.5 x upper limit of normal (ULN), alkaline phosphatase ≤5x ULN, and serum transaminase (either AST or ALT) ≤ 5 x ULN(within 1 week prior to randomization);
- •Written informed consent for participation in the trial.
排除标准
- •Previous exposure to prior cancer therapy (chemotherapy, radiotherapy or intervention therapy) for colon cancer.
- •Patients with known hypersensitivity reactions to any of the components of the study treatments.
- •Other previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
- •Pregnancy (absence confirmed by serum/urine β-HCG) or breast-feeding
- •Known drug abuse/ alcohol abuse
- •Legal incapacity or limited legal capacity
- •Pre-existing peripheral neuropathy.
研究组 & 干预措施
IPC plus AC
patients treated with intraoperative intraportal chemotherapy (IPC) plus adjuvant chemotherapy (AC; mFOLFOX6).; IPC: During the operation, one dose of fluorodeoxyuridine (FUDR) 1000 mg and oxaliplatin 100 mg were administered as a bolus into the regional vein within 5 minutes just before ligation.
AC: All patients received mFOLFOX6 adjuvant chemotherapy, consisting of a 2-h infusion of 85 mg/m2 oxaliplatin given simultaneously with a 2-h infusion of 400 mg/m2 LV, followed by a bolus of 400 mg/m2 5-FU, and then a continuous infusion of 2000 mg/m2 5-FU given on 2 consecutive days by intravenous pumping every 14 days for 12 cycles.[1] Adverse events were categorized according to National Cancer Institute Common Toxicity Criteria, version 3.0.
干预措施: FUDR +oxaliplatin (Drug)
IPC plus AC
patients treated with intraoperative intraportal chemotherapy (IPC) plus adjuvant chemotherapy (AC; mFOLFOX6).; IPC: During the operation, one dose of fluorodeoxyuridine (FUDR) 1000 mg and oxaliplatin 100 mg were administered as a bolus into the regional vein within 5 minutes just before ligation.
AC: All patients received mFOLFOX6 adjuvant chemotherapy, consisting of a 2-h infusion of 85 mg/m2 oxaliplatin given simultaneously with a 2-h infusion of 400 mg/m2 LV, followed by a bolus of 400 mg/m2 5-FU, and then a continuous infusion of 2000 mg/m2 5-FU given on 2 consecutive days by intravenous pumping every 14 days for 12 cycles.[1] Adverse events were categorized according to National Cancer Institute Common Toxicity Criteria, version 3.0.
干预措施: oxaliplatin+Leucovorin+5-FU (Drug)
AC
patients treated with adjuvant chemotherapy (AC; mFOLFOX6) alone after surgery; Adjuvant chemotherapy (AC): All patients received mFOLFOX6 adjuvant chemotherapy, consisting of a 2-h infusion of 85 mg/m2 oxaliplatin given simultaneously with a 2-h infusion of 400 mg/m2 LV, followed by a bolus of 400 mg/m2 5-FU, and then a continuous infusion of 2000 mg/m2 5-FU given on 2 consecutive days by intravenous pumping every 14 days for 12 cycles.[1] Adverse events were categorized according to National Cancer Institute Common Toxicity Criteria, version 3.0.
干预措施: oxaliplatin+Leucovorin+5-FU (Drug)
结局指标
主要结局
disease-free survival
时间窗: up to 5 year
DFS was defined as from the date of randomization to the date of tumor recurrence or death from any cause.
次要结局
- overall survival(3 year and 5 year)
- metastasis-free survival(3 year and 5 year)
- adverse events of Chemotherapy and IPC(6 months)
研究者
Xu jianmin
Deputy director of the colorectal cancer center, Fudan University
Fudan University