Early Commencement of Adjuvant Chemotherapy for Stage III Colon Cancer: a Multicenter Randomized Trial
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 303
- 试验地点
- 2
- 主要终点
- 3-year disease free survival rate
研究概览
简要总结
This study sets up the final study end point and three detailed goals as the following.
The main objective of study: This trial is done to assess the safety and benefit of early adjuvant chemotherapy from 10 to 14 days after surgery compared with conventional commencement after 2weeks for treatment of patients with colon cancer.
Detailed goal of study:
The primary endpoint: This study is designed to assess whether early commencement of adjuvant chemotherapy improves the 3-year disease-free survival, overall survival and recurrence rate.
The secondary endpoint: This study aims to compare short-term cumulative complications between early and conventional commencement of adjuvant chemotherapy after laparoscopic resection of colon cancer. This study will also assess the quality of life and side effects of chemotherapy.
详细描述
Chemotherapy regimen: FOLFOX-6, every 2weeks, total 12 cycles treatment
-
day1: Oxaliplatin 85mg/m2
-
day1: Leucovorin 200mg/m2
-
day1: 5-FU 400mg/m2 IV bolus
-
2,400mg/m2 over 46 hours
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligibility rule of enrollment
- •Rectal adenocarcinoma that were 15 cm or more from the anal verge
- •pathologically diagnosed stage II or III disease
- •patients who meet the discharge criteria within 10days after surgery
- •Patients with adequate hepatic, renal, and bone marrow function, and a left ventricular ejection fraction of 55% or higher measured by echocardiography
排除标准
- •An ineligibility to participate in the clinical study based on the judgment of investigators from a legal perspective
- •A past history of chemotherapy
- •tumor with obstruction or perforation
- •tumor with distant metastases
- •synchronous tumor
- •relative or absolute contraindications of chemotherapy
- •Recent MI, CVA, nitrate medication
- •Severe cardiovascular disease, psychiatric disease
- •Severe hepatic dysfunction (GOT, GPT ≥100IU/L)
- •Renal dysfunction (Cr ≥2mg/dl)
- •The concurrent presence of other severe medical diseases
研究组 & 干预措施
early commencement
Individuals who initiate the adjuvant chemotherapy from 10 to 14 days after surgery
干预措施: timing to initiate the adjuvant FOLFOX chemotherapy (Drug)
conventional commencement
Individuals who initiate the adjuvant chemotherapy after 14 days after surgery
干预措施: timing to initiate the adjuvant FOLFOX chemotherapy (Drug)
结局指标
主要结局
3-year disease free survival rate
时间窗: up to 3 years after operation
A survival analysis will be performed using the Kaplan-Meier method, for which a comparison of the survival curve will also made using a Log-rank test.
次要结局
- side effects of chemotherapy(during chemotherapy period)
- short-term cumulative surgery-related complications during chemotherapy(up to 26 weeks after operation)
研究者
Gyu-Seog Choi
Professor
Kyungpook National University Hospital