Neoadjuvant Chemotherapy Versus Standard Treatment in Patients With Locally Advanced Colon Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 9
- 主要终点
- Two-year disease free survival
研究概览
简要总结
The purpose of this study is to compare 3 cycles of neoadjuvant (preoperative) chemotherapy + operation with the standard treatment of locally advanced colon cancer, which is operation + 8 cycles of (adjuvant) chemotherapy.
Patients receiving neoadjuvant chemotherapy may not need adjuvant chemotherapy after the operation and, if this is the case, they will be spared of 5 cycles of chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- •Histologically verified locally advanced T3 (ETI > 5 mm) or T4 colon cancer assessed by CT scan.
- •Age ≥ 18 years
- •Hematology ANC ≥1.5x10^9/l. Thrombocytes ≥ 100x10^9/l.
- •Biochemistry Bilirubinemia ≤ 3 x upper normal level. ALAT ≤ 5 x upper normal value
- •Consent to translational research
- •Fertile women must present a negative pregnancy test and use secure contraceptives during and 3 months after treatment.
- •Written and orally informed consent.
排除标准
- •Patients with distant metastases.
- •Acute operation
- •Clinically significant cardiovascular disease (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before inclusion.
- •Active, serious infection or other serious disease.
- •Peripheral neuropathy NCI grade > 1
- •Other malignant disease within 5 years prior to study enrollment, except basocellular or squamous skin cancer and carcinoma in situ cervicis uteri.
- •Other investigational treatment within 30 days prior to treatment start.
- •Hypersensitivity to one or more of the active or auxiliary substances.
研究组 & 干预措施
A, Conventional treatment
Operation + 4 or 8 cycles of adjuvant chemotherapy, if indicated.
干预措施: Oxaliplatin (Drug)
A, Conventional treatment
Operation + 4 or 8 cycles of adjuvant chemotherapy, if indicated.
干预措施: Capecitabine (Drug)
B, Neoadjuvant chemotherapy
3 cycles of neoadjuvant chemotherapy + operation. Adjuvant chemotherapy only if indicated.
干预措施: Capecitabine (Drug)
B, Neoadjuvant chemotherapy
3 cycles of neoadjuvant chemotherapy + operation. Adjuvant chemotherapy only if indicated.
干预措施: Oxaliplatin (Drug)
结局指标
主要结局
Two-year disease free survival
时间窗: 2 years after completed study treatment
次要结局
- Rate of patients fulfilling the criteria for adjuvant chemotherapy(6, 12, 18, and 24 months after completed study treatment)