The ADAPTA Study: ADjuvant chemotherAPy After Curative Intent resecTion of Ampullary Cancer. A Pan-European Prospective Multicenter Double Single Arm Cohort Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Disease-free survival (3y)
研究概览
简要总结
Ampullary adenocarcinoma (AAC) is a rare gastrointestinal cancer with varying survival rates, particularly the aggressive pancreatobiliary (PB) subtype. Adjuvant therapy benefits only PB and mixed subtype patients, while prospective studies are required for validation. A study proposes tailored adjuvant treatments (CAPOX for intestinal subtype, FOLFIRINOX for PB and mixed subtypes) based on histopathology to enhance survival, also exploring molecular sub-studies for deeper insights.
详细描述
Background:
Ampullary adenocarcinoma(AAC) is rare. 5-year survival rates of 30% to 70% are seen after resection. This broad range of survival could be explained by the morphological heterogeneity in the three subtypes of AAC (pancreatobiliary, intestinal and mixed subtype), which complicates the prediction of individual prognosis and clinical decision making with regard to adjuvant therapy. To date there are no prospective studies to elucidate whether adjuvant chemotherapy improves survival in these patients.
Methods/design:
The ADAPTA study is a phase II prospective single arm multicenter cohort study including 200 patients with resected AAC (100 patients with intestinal subtype, and 100 with pancreatobiliary- and mixed subtype). All patients will be treated with CAPOX/ FOLFIRINOX respectively. Outcomes will be compared after propensity score matching to data of all patients in consecutive participating centers not treated according to the proposed regime.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients with histologically or cytologically confirmed AAC with subtyping of pancreatobiliary/mixed subtype or intestinal subtype
- •After curative resection for ampullary cancer without metastatic disease.
- •WHO performance status 0 or 1
- •Able and willing to receive adjuvant chemotherapy
- •R0/ R1 resection
- •Age ≥ 18 years
- •Written informed consent
排除标准
- •Prior radiotherapy, chemotherapy, or resection for AAC.
- •Previous malignancy (excluding non-melanoma skin cancer), unless no evidence of disease and diagnosed more than 5 years before diagnosis of AAC.
- •Pregnancy.
- •R2 resection.
- •Adjuvant chemotherapy started more than 12 weeks after surgery (aim to start within 8 weeks)
- •Serious concomitant systemic disorders that would compromise the safety of the patient or his/her ability to complete the study, at the discretion of the investigator.
- •Known hypersensitivity or contraindications against capecitabine, 5 FU, Irinotecan, or Oxaliplatin
- •Inadequate organ functions, characterized by:
- •Leucocytes (WBC) < 3.0 X 109/l
- •Neutrophils < 1.500 (count per microliter of blood)
- •Platelets < 100 x 109 /l
- •Hemoglobin < 8 mmol/l
- •Renal function: E-GFR < 50 ml/min (serum creatinine < 1.5 x UNL)
- •cholestasis with elevated levels of bilirubin and/or alkaline phosphatase > 3x UNL (can be improved by biliary drainage if necessary)
- •elevated transaminases (ALAT/ASAT) ≥ 5 x UNL
- •hypoalbuminemia < 2.5 g/dl
- •Inadequate coagulation status INR > 2 or Quick < 50%, aPTT >50 sec in the absence of any drugs interfering with coagulation such as acenocoumarin, warfarin, phenprocoumon, NMH or UFH.
研究组 & 干预措施
Intestinal-type ampullary adenocarcinoma intervention
This cohort consist of patients with intestinal-type ampullary adenocarcinoma who are able to receive adjuvant chemotherapy.
干预措施: Capox (Drug)
Pancreatobiliary/mixed-type ampullary adenocarcinoma intervention
This cohort consist of patients with Pancreatobiliary/mixed-type ampullary adenocarcinoma who are able to receive adjuvant chemotherapy.
干预措施: Folfirinox (Drug)
结局指标
主要结局
Disease-free survival (3y)
时间窗: 3 years
Disease-free survival (DFS) refers to the length of time after treatment for a disease in months, such as cancer, during which no signs or symptoms of the disease recur or progress. It is a crucial measure in assessing the effectiveness of a treatment regimen in preventing the return of the disease. In cancer contexts, DFS focuses on the period without disease recurrence or progression, highlighting the success of the treatment in controlling the illness.
次要结局
- Quality of Life questionnaire (qualitative outcome)(3 years)
- Overall survival (3y)(3 years)
- Disease-free survival (5y)(5 years)
- Overall survival (5y)(5 years)