Adjuvant Chemoradiotherapy Versus Chemotherapy for Post-operative Pancreatic Cancer
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 770
- 试验地点
- 1
- 主要终点
- Disease progression free survival will be determined.
研究概览
简要总结
In this trial, we aim to compare the outcomes of adjuvant chemoradiotherapy with chemotherapy for patients with resected pancreatic cancer who are at high risk of disease progressions.
详细描述
Pancreatic cancer is a lethal malignancy with the lowest 5-year overall survival rate of 9% and an increasing incidence. In China, the mortality of pancreatic cancer ranked the sixth among all cancers. Although surgical resection is the only radical treatment, only less than 20% patients could receive upfront surgery at the initial diagnosis. Even though patients have surgery, the incidence of disease progressions, including local progression and metastasis, is about 80-90%. In NCCN guidelines and Chinese guidelines, adjuvant chemotherapy is recommended for post-operative pancreatic cancer, while adjuvant chemoradiotherapy could also be used. However, it has not been clarified that which patients may benefit from adjuvant chemoradiotherapy, and no high-level evidence has shown the advantages of adjuvant chemoradiotherapy over chemotherapy. In meta-analyses, it was demonstrated that patients with lymph nodes metastases, R1 or R2 resection or lymphovascular invasion could achieve longer survival after adjuvant chemoradiotherapy compared with chemotherapy. Therefore, we aim to compare the outcomes of adjuvant chemoradiotherapy with those of chemotherapy in patients with lymph nodes metastases, R1 or R2 resection or lymphovascular invasion after surgical resection of pancreatic cancer.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-75 years
- •Pathologically confirmed pancreatic ductal adenocarcinoma
- •Pathologically confirmed lymph node metastasis, R1 or R2 resection or lymphovascular invasion (one of the risk factors)
- •No history of cancer treatment after surgical resection
- •No disease progression confirmed by imaging examinations
- •ECOG 0 to1 point
- •No abnormality in blood routine test, liver and kidney function test and coagulation test (White blood cell count ≥4.0×10^9/L, neutrophil count ≥2.0×10^9, hemoglobin level ≥100g/L, platelet count ≥100×10^9/L, ALT and AST level < 2.5 times the upper limit of normal, total bilirubin and creatinine level within the normal, international normalized ratio <2)
排除标准
- •History of cancer treatment after surgical resection
- •History of other cancers within 5 years
- •Disease progression, including local pprogression or metastasis, confirmed by imaging examinations
- •ECOG ≥2 points
- •Significant abnormality in blood routine test, liver and kidney function test and coagulation test
- •Active inflammatory bowel disease
- •Gastrointestinal bleeding or perforation within 6 months
- •Infections requiring antibiotics
- •Heart or respirotory insufficiency
- •Pregnant women or breastfeeding women
研究组 & 干预措施
adjuvant chemoradiotherapy
Chemotherapy: Gemcitabine plus capecitabine Gemcitabine, 1000mg/m2，d1, 8, every 3 weeks as a cycle. Capecitabine, 1650-2000mg/m2，bid, d1-14, every 3 weeks as acycle. A total of 6 cycle should be delivered.
Chemoradiotherapy: 2-3 weeks after chemotherapy, adjuvant chemoradiotherapy is given. Radiation dose: 50-54Gy (1.8-2.0Gy per fraction). Concurrent capecitabine, 1650mg/m2，bid.
干预措施: Adjuvant chemoradiotherapy (Combination Product)
adjuvant chemotherapy
Gemcitabine, 1000mg/m2，d1, 8, every 3 weeks as a cycle. Capecitabine, 1650-2000mg/m2，bid, d1-14, every 3 weeks as acycle. A total of 6 cycle should be delivered.
干预措施: Adjuvant chemotherapy (Drug)
结局指标
主要结局
Disease progression free survival will be determined.
时间窗: 3 years
The time from the start of treatment until documentation of any clinical or radiological disease progression or death, whichever occurred first. Progression is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST; version 1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
次要结局
- Overall survival will be determined.(3 years)
- Quality of life will be determined.(3 years)
- Treatment-related adverse events will be determined.(3 years)