PRODIGE 98- AMPIRINOX : Randomized, multicenter, Phase III trial of adjuvant chemotherapy with modified FOLFIRINOX versus capecitabine or gemcitabine in patients with resected ampullary adenocarcinoma.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 294
- 试验地点
- 53
- 主要终点
- The primary endpoint is the 2 years Disease-free survival rate. DFS will be calculated from date of randomization to the date of first relapse (locally and/or metastatic) or date of death (all causes). Patients alive without relapse will be censored at the date of last news. Second cancer will not be considered as an event. The relapse will be assessed by the investigator according to RECIST v1.1 criteria.
研究概览
简要总结
To assess efficacy of adjuvant mFOLFIRINOX versus single-agent chemotherapy (gemcitabine or capecitabine) in improving 2-year disease-free survival (DFS) after surgical resection of an ampullary adenocarcinoma
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Histologically proven adenocarcinoma on surgical specimen
- •Macroscopically complete surgical resection of an ampullary adenocarcinoma (R0 or R1)
- •Adenocarcinoma removed within 12 weeks prior to enrollment
- •Patient without metastatic disease on CT scan < 4 weeks prior to inclusion
- •CA19.9 level < 180 U/L at inclusion (post-operative level)
- •Patients ≥ 18 years of age
排除标准
- •Neoadjuvant systemic chemotherapy
- •AST or ALT > 2.5 x UNL, alkaline phosphatase > 2.5x normal at least 15 days after resection
- •Patients with poor nutritional status represented by albuminemia < 30.0g/dl
- •History of myocardial infarction within the last 6 months, severe coronary artery disease or severe heart failure
- •pT1N0M0 tumors
- •Active infection by HBV, HCV or HIV
- •Known dihydropyrimidine dehydrogenase deficiency (uracilemia ≥ 16 ng/mL)
- •Pre-existing peripheral neuropathy (grade ≥ 2)
- •Unresolved or uncontrolled concomitant medical conditions
- •Neutrophils < 1500/mm3, platelets < 150 000/mm3, Haemoglobin < 9 g/dL
- •Total bilirubin > 1.5x normal
- •Creatinine clearance < 50 ml/min according to MDRD
结局指标
主要结局
The primary endpoint is the 2 years Disease-free survival rate. DFS will be calculated from date of randomization to the date of first relapse (locally and/or metastatic) or date of death (all causes). Patients alive without relapse will be censored at the date of last news. Second cancer will not be considered as an event. The relapse will be assessed by the investigator according to RECIST v1.1 criteria.
The primary endpoint is the 2 years Disease-free survival rate. DFS will be calculated from date of randomization to the date of first relapse (locally and/or metastatic) or date of death (all causes). Patients alive without relapse will be censored at the date of last news. Second cancer will not be considered as an event. The relapse will be assessed by the investigator according to RECIST v1.1 criteria.
次要结局
- OS is defined as the time between randomization and death (all causes). Patients alive will be censored at the date of last news.
- Rate of patients completing 3 and 6-month chemotherapy schedule according to percentage of administered dose of each product. Percentage of administrated dose will be calculated as the ratio of dose received over dose planned for each product. A completed cycle will be defined by at least 80% of each product dispensed
- All grade and grade 3-4, will be described using NCI-CTCAE (National Cancer Institute – Common Terminology Criteria for Adverse Events) version 5.0
- Quality of life will be assessed according to the questionnaire of EORTC QLQ-C30 and PAN26 questionnaires.
研究者
Coordinator
Scientific
Centre Hospitalier Universitaire De Dijon