Evaluation and Comparison of the Efficacy of a New Standard Pre-operative Chemotherapy for Stage II and III Colorectal Cancer According to the FOLFOX4 Regimen With Routine Chemoradiation Therapy
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- disease-free survival
研究概览
简要总结
Phase II, Multicenter, Open-label, Randomized Study evaluating neoadjuvant chemotherapy (FOLFOX4) in patients with stage II and III colorectal cancer with standard chemoradiation Defined by Magnetic Resonance Imaging
详细描述
This is a biomedical research, phase II, multicenter, open-label, randomized study, comparing neoadjuvant CT with FOLFOX4, versus immediate preoperative chemoradiotherapy (CRT), in patients with locally advanced rectal cancer. Randomization in a 1: 1 ratio, neoadjuvant chemotherapy or chemoradiation. The purpose of the study is to evaluate the efficacy, tolerability, and comparability of new standard preoperative chemotherapy with FOLFOX4 in patients with stage II and III colorectal cancer compared to routine chemoradiation.
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
- •diagnosed with rectal adenocarcinoma;
- •radiologically measurable tumor size;
- •general condition (ECOG 0-2 points);
- •stage II or III rectal tumor clinically (pelvic MRI and endorectal ultrasound),
- •in the absence of long-term spread of the disease (confirmed by radiological examinations (computed tomography of the thorax and abdomen));
- •during preoperative proctoscopy, the tumor is detected 0 -15 cm from the anus;
- •Blood tests 28 days before the start of treatment:
- •and general blood count: neutrophils greater than 1.5x10 9 / l, platelets greater than 100 x 10 9 / l, Hemoglobin greater than 80 g / l, liver enzymes (Aspartate aminotransferase (AST/GOT), alanine aminotransferase (ALT/GPT) not more than 3 times upper limit), and renal function (creatinine up to 1.5 times the upper limit of normal) is normal; women of childbearing potential - negative pregnancy test;
- •A signed informed consent form.
排除标准
- •patients with signs of intestinal obstruction at the start of treatment;
- •previous lower abdominal radiation therapy;
- •other tumors over a five-year period;
- •pregnant or breastfeeding women;
- •men and women of childbearing potential who do not agree to use adequate contraception;
- •Patient co-morbidities that would make the patient unsuitable for this study or significantly interfere with the assessment of safety and toxicity.
研究组 & 干预措施
Arm A (Control): Radiotherapy + fluorouracil
Chemoradiotherapy 5 weeks (50 Grays (Gy), 2 Gy/session; 25 fractions) + fluorouracil/leucovorin 400 mg/m² 1-4 day the first and fifth weeks of radiotherapy) , then 6-8 weeks after chemoradiation, surgery, followed by adjuvant chemotherapy for 4-6 months, either Folfox4 or fluorouracil, depending on the center's choice.
干预措施: Radiotherapy 50 Gy (Radiation)
Arm A (Control): Radiotherapy + fluorouracil
Chemoradiotherapy 5 weeks (50 Grays (Gy), 2 Gy/session; 25 fractions) + fluorouracil/leucovorin 400 mg/m² 1-4 day the first and fifth weeks of radiotherapy) , then 6-8 weeks after chemoradiation, surgery, followed by adjuvant chemotherapy for 4-6 months, either Folfox4 or fluorouracil, depending on the center's choice.
干预措施: Fluorouracil/folic acid (Drug)
Arm B (Experimental): Chemotherapy with Oxaliplatin, fluorouracil, folinic acid (FOLFOX4) regimen
Neoadjuvant CT FOLFOX4, 8 cycles (ca. 4 months; each cycle = 2 weeks):
oxaliplatin: 85 mg/m² in 2 hours at D1; folinic acid: 100 mg/m² simultaneously in 2 hours at D1 and D2 during the Oxaliplatin; bolus 5-fluorouracil (5-FU) 400mg/m² D1+D2; infusion 5-fluorouracil (5-FU): 600 mg/m² continuous infusion during 22hours at D1 and D2, every 14 days during 42 months (8 cycles).
干预措施: Chemotherapy in regimen with Oxaliplatin, fluorouracil, folinic acid (FOLFOX4) (Drug)
Arm B (Experimental): Chemotherapy with Oxaliplatin, fluorouracil, folinic acid (FOLFOX4) regimen
Neoadjuvant CT FOLFOX4, 8 cycles (ca. 4 months; each cycle = 2 weeks):
oxaliplatin: 85 mg/m² in 2 hours at D1; folinic acid: 100 mg/m² simultaneously in 2 hours at D1 and D2 during the Oxaliplatin; bolus 5-fluorouracil (5-FU) 400mg/m² D1+D2; infusion 5-fluorouracil (5-FU): 600 mg/m² continuous infusion during 22hours at D1 and D2, every 14 days during 42 months (8 cycles).
干预措施: Radiotherapy 50 Gy (Radiation)
结局指标
主要结局
disease-free survival
时间窗: 3 year
To compare the 3-year disease-free survival between the investigational arm and the control arm.
次要结局
- Overall survival(7 year)
研究者
Rita Ambraziene
Sub-Investigator
Lithuanian University of Health Sciences