Neoadjuvant Plus Adjuvant or Only Adjuvant Nab-Paclitaxel Plus Gemcitabine for Resectable Pancreatic Cancer: A Prospective, Randomized, Controlled, Phase II Study of the AIO (Working Group for Medical Oncology From the German Cancer Society) Pancreatic Cancer Group
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 1
- 主要终点
- Time to Disease free survival (DFS)
研究概览
简要总结
NEONAX is an interventional, prospective, randomized, controlled, open label, two sided survival phase II studies against a fixed survival probability, with an unconnected analysis of the results in both experimental arms.
Determining the impact of 2 cycles of Perioperative nab-paclitaxel/gemcitabine followed by surgery and 4 cycles of adjuvant nab-paclitaxel/gemcitabine or 6 cycles of adjuvant nab-paclitaxel/gemcitabine on the Disease free survival (DFS) rate at 18 months post randomization
详细描述
The planned trial will enable us to address the following issues:
- Identification of patients who benefit from surgery. Tumor progress during intensified Perioperative chemotherapy is likely to indicate a particularly poor prognosis suggesting that these patients would not have benefitted from immediate surgery.
- Assess tumor response/downsizing using nab-paclitaxel/gemcitabine also at the molecular level
- Can we achieve a better systemic tumor control or reduce the metastatic spread using nab-paclitaxel/gemcitabine compared to adjuvant gemcitabine
- Examining the effect of a more efficacious chemotherapy regimen (nab-paclitaxel/gemcitabine) in the adjuvant setting
- Defining the impact of a perioperative or adjuvant chemotherapy with gemcitabine/nab-paclitaxel on DFS and 3-year Overall survival (OS)
Histopathological tumor regression will be evaluated in addition to tumor size measurement according to Response Evaluation Criteria In Solid Tumors (RECIST). We will establish a histopathological tumor regression score to evaluate the efficacy of the neoadjuvant treatment. For this score we will examine tumor core biopsies obtained prior to neoadjuvant treatment and histological tumor specimen after surgery in both arms.
To reliably determine R0 resections, the resected specimen will be prepared for pathology in a defined manner according to the procedure set out in the German S3 guidelines for pancreatic cancer.
This trial provides the unique opportunity in pancreatic cancer to obtain material prior to and after surgery for biomarker analysis and correlation with outcome. We will perform pharmacogenomic candidate gene analysis of hENT1 (human equilibrative nucleoside transporter-1), CDA (cell differentiation agent), DCK (Desoxycytidin-Kinase) and 5´nucleotidase in both arms.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
perioperative nab-paclitaxel/gemcitabine
neoadjuvant chemotherapy (8 weeks) preceding surgery (3 weeks after completion of chemotherapy) followed by adjuvant chemotherapy (16 weeks, begin within 12 weeks after surgery)
干预措施: perioperative nab-paclitaxel/gemcitabine (Drug)
adjuvant nab-paclitaxel/gemcitabine
Surgery followed by adjuvant chemotherapy (24 weeks, begin within 12 weeks after surgery), follow-up per patient: Until end of study or death
干预措施: adjuvant nab-paclitaxel/gemcitabine (Drug)
结局指标
主要结局
Time to Disease free survival (DFS)
时间窗: 18 months after randomization
To improve the DFS rate at 18 months in at least one arm to≥ 55%
次要结局
- toxicity(57 months)
- Tumor response(66 months)
- morbidity and mortality(7 years)
- Disease progression(7 years)
- Safety(57 months)
- Overall survival(7 years)
- tumor recurrence(7 years)
- quality of life(57 months)
- pharmacogenomic markers, tumor-biomarkers and molecular analyses(57 months)
- Tumor recurrence(66 months)
- resection rate(53 months)
- Correlation of tumor regression and R0 resection(57 months)