2024-517489-41-00招募中3 期
IROCAS : A Phase III, Randomised, international trial comparing mFOLFIRINOX triplet chemotherapy to mFOLFOX for highrisk stage III colon cancer in adjuvant setting
Unicancer, Unicancer78 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2024年10月10日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 66
- 试验地点
- 78
- 主要终点
- The primary end-point is the Disease Free Survival (DFS) at 3 years, defined as the time from the date of randomization up to the date of: - first local, regional or distant relapse; - second colorectal cancer; - death from any cause included treatment-related death. Other primary cancer (except second primary colorectal) will be ignored.
研究概览
简要总结
The primary objective is the 3-year Disease Free Survival rate.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Patient ≥18 years and < 75 years
- •Adequate contraception if applicable.
- •Patient able and willing to comply with study procedures as per protocol
- •Patient able to understand and willing to sign and date the written voluntary informed consent form at screening visit prior to any protocol-specific procedures
- •Public or private health insurance coverage
- •Life expectancy of > or = at 5 years
- •Uracilemia < 16 ng/ml (only for french centers)
- •Patient ≥18 years and <71 years must have an ECOG ≤1 – Patients ≥71 years and < 75 years must have an ECOG = 0
- •Pathologically confirmed high-risk stage III colon adenocarcinoma, restricted to pT4N1 or pT1-4N2 tumor.
- •Curative R0 surgical resection.
- •Patients who have undergone surgery for colon cancer, defined as a tumor location >12 cm from the anal verge by endoscopy and/or above the peritoneal reflection at surgery (high rectum), without gross or microscopic evidence of residual disease after surgery with curative intent
- •Start of study drug treatment has to be performed less than 56 days after surgery.
- •No prior chemotherapy.
- •No prior abdominal or pelvic irradiation.
- •Patient with adequate organ function: - Absolute neutrophil count (ANC) ≥ 2 x 109/L - Haemoglobin ≥9 g/dL - Platelets (PTL) ≥100 x 109/L - AST/ALT ≤2.5 x ULN - Alkaline phosphatase ≤2.5 x ULN - Total Bilirubin ≤1.5 x ULN (Upper Limit of Normal) - Creatinine clearance ≥50 mL/min (Cockcroft and Gault formula) - Kalemia, magnesemia, calcemia ≥ 1 LLN (Lower Limit of Normal) - Carcinoembryogenic antigen (CEA) ≤10ng/mL after surgery (during screening period)
排除标准
- •Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to study treatment start. Incompletely healed wounds or anticipation of the need for major surgical procedure during the course of the study
- •Any significant disease which, in the investigator’s opinion, would exclude the patient from the study.
- •Patient with a DPD deficiency or UGT1A1 homozygous 7/7; the test should be done for all patients before 5-FU administration, according to ANSM communication regarding recommendation about high risk of no testing DPD in patient before 5-FU administration;
- •Patients already included in another therapeutic trial involving an experimental drug
- •Metastatic disease
- •Presence of inflammatory bowel disease and/or ileus
- •Known hypersensitivity reaction to any of the components of study treatments.
- •Pregnancy (absence to be confirmed by β-hCG test) or breast-feeding period
- •Clinically relevant coronary artery disease or history of myocardial infarction in the last 12 months, or high risk of uncontrolled arrhythmia (for men: QTc ≥450 msec, for women: QTc ≥470 msec)
- •Previous malignancy in the last 5 years except curative treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix
- •Medical, geographical, sociological, psychological or legal conditions that would not permit the patient to complete the study or sign informed consent
- •History or current evidence on physical examination of central nervous system disease or peripheral neuropathy ≥ grade 1 Common Toxicity Criteria for Adverse Events (CTCAE) v4.03.
结局指标
主要结局
The primary end-point is the Disease Free Survival (DFS) at 3 years, defined as the time from the date of randomization up to the date of: - first local, regional or distant relapse; - second colorectal cancer; - death from any cause included treatment-related death. Other primary cancer (except second primary colorectal) will be ignored.
The primary end-point is the Disease Free Survival (DFS) at 3 years, defined as the time from the date of randomization up to the date of: - first local, regional or distant relapse; - second colorectal cancer; - death from any cause included treatment-related death. Other primary cancer (except second primary colorectal) will be ignored.
次要结局
- Evaluation of Efficacy: The evaluation of efficacy is defined as the Disease Free Survival at 2 years, defined as the time from the date of randomization up to the date of: - first local, regional or distant relapse - second colorectal cancer - death from any cause included treatment-related death. Other primary cancer (except second primary colorectal) will be ignored.
- Overall Survival (OS): Overall Survival (OS) is defined as the time from the date of randomization to the date of documented death from any cause.
- Evaluation of Toxicity: Safety of the study treatment will be assessed on occurrence of Adverse Events (AEs), intake of concomitant treatments, per-treatment arising changes in physical examination, vital signs (blood pressure, pulse rate and body temperature), ECG, and clinical laboratory tests (biochemistry, haematology). Safety parameters will be graded based on NCI CTCAE v4.03 classification.
研究者
Nourredine AIT RAHMOUNE
Scientific
Unicancer
研究点 (78)
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