NCT06813976招募中3 期
PRODIGE 98 : Randomized, Multicenter Phase 3 Trial of Adjuvant Chemotherapy With Modified FOLFIRINOX Versus Capecitabine or Gemcitabine in Patients With Resected Ampullary Adenocarcinoma
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 294
- 试验地点
- 1
- 主要终点
- Disease-free survival (DFS)
研究概览
简要总结
Ampullary adenocarcinoma (AMPAC) is a rare cancer (0.2% of digestive cancers) affecting the ampulla of Vater. The only curative treatment is surgery, but around 4% of patients recur within 2 years of surgical resection.
The aim of adjuvant chemotherapy is to reduce the risk of disease recurrence, and the only chemotherapies that can be considered standard to date are capecitabine and gemcitabine.
In this trial, an alternative experimental treatment strategy using modified FOLFORINOX (mFOLFORINOX) is proposed. It consists of 3 chemotherapies with complementary actions: 5-fluorouracil, irinotecan and oxaliplatin, combined with folic acid a vitamin that enhances the efficacy of 5-fluorouracil.
This study proposes 2 treatment schemes:
- Group A: mFOLFIRINOX: oxaliplatin, irinotecan, 5-fluorouracil, with folinic acid,
- group B: mono-chemotherapy with capecitabine or gemcitabine.
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
- •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
- •Patients ≥ 18 years of age
- •Patient without metastatic disease on CT scan < 4 weeks prior to inclusion
- •WHO performance status 0 or 1 (WHO 0 if age >75)
- •Normal values of kalemia, magnesemia and calcemiaPatient able to understand and sign the information and informed consent note
- •Women of childbearing age and men who are sexually active with women of childbearing age must agree to use highly effective contraception during the trial treatment at least until 6 months after the end of experimental treatment. Women of childbearing potential must use highly effective contraception at least 9 months after the end of treatment with oxaliplatin
- •Patient affiliated to a social security scheme for France, or equivalents in European countries
- •CA19.9 level < 180 U/L at inclusion (post-operative level)
排除标准
- •Neoadjuvant systemic chemotherapy
- •pT1N0M0 tumors
- •Active infection by HBV, HCV or HIV
- •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
- •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
- •Active and/or potentially severe infection
- •Treatment with a strong cytochrome P450 inhibitor within 4 weeks prior to the administration of the protocol treatment (Treatment with Hypericum perforatum)
- •Patient under treatment by brivudine, or treated by brivudine within 4 weeks prior to beginning of study treatment
- •Concomitant use with St John's Wort
- •QT/QTc interval longer than 450msec for men and longer than 470msec for women on the ECG
- •Hypersensitivity to any of the study products or their excipients
- •Administration of live vaccines within 28 days prior to randomization
- •Other cancer treated within the last 5 years except adequately treated, in situ cervical carcinoma or basocellular/spinocellular carcinoma
- •chronic bowel disease requiring specific treatment and/or intestinal obstruction
- •Pregnant or breastfeeding woman
- •Person under guardianship
- •Inability to undergo the medical follow-up of the trial for geographical, social or psychological reasons
研究组 & 干预措施
Experimental strategy
Experimental
干预措施: mFOLFORINOX (Drug)
Experimental strategy
Experimental
干预措施: Biological assessment (Biological)
Experimental strategy
Experimental
干预措施: Paraclinical examinations (Diagnostic Test)
Standard treatments
Active Comparator
干预措施: Capecitabine or gemcitabine (Drug)
Standard treatments
Active Comparator
干预措施: Biological assessment (Biological)
Standard treatments
Active Comparator
干预措施: Paraclinical examinations (Diagnostic Test)
结局指标
主要结局
Disease-free survival (DFS)
时间窗: Assessed up to 36 months
To compare DFS between the 2 arms of treatments in randomized patients
次要结局
未报告次要终点
研究者
研究点 (1)
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