Adjuvant Gemcitabine Versus Gemcitabine With Chemoradiation in Pancreatic Adenocarcinoma With R1 Resection and/or Positive Lymph Nodes
试验速览
- 阶段
- 2 期
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Disease free survival
研究概览
简要总结
Adjuvant Gemcitabine Versus Gemcitabine With Chemoradiation in Pancreatic Adenocarcinoma With R1 Resection and/or Positive Lymph Nodes after curative resection.
详细描述
Adjuvant Gemcitabine Versus Gemcitabine With TS-1 based Chemoradiation in Pancreatic Adenocarcinoma With R1 Resection and/or Positive Lymph Nodes after curative resection: a randomized phase II study.
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
- 是
入选标准
- •Histologically confirmed resected ductal pancreatic adenocarcinoma with R1 resection and/or positive lymph nodes.
- •Subject should start treatment no later than 10 weeks postsurgery.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Acceptable hematology parameters:
- •Absolute neutrophil count ≥1500 cell/mm3
- •Platelet count ≥100,000/mm3
- •Hemoglobin (Hgb) ≥8.0 g/dL
- •Acceptable blood chemistry levels:
- •Aspartate aminotransferase (AST) and Alanine transaminase (ALT) ≤2.5 × upper limit of normal range (ULN)
- •Total bilirubin ≤ 2.5 x upper Limit of Normal (ULN)
- •Serum creatinine within upper limits of normal.
- •Cancer antigen (CA)19-9 ≤ 2.5 x upper Limit of Normal (ULN) assessed within 14 days of randomization.
- •No disease recurrence or metastases detected on CT/MRI assessed within 30 days of randomization.
- •Signed informed consent.
排除标准
- •R2 resection or presence of metastatic disease.
- •Prior neo-adjuvant treatment or radiation therapy for pancreatic adenocarcinoma.
- •Any other malignancy within 5 years prior to randomization, with the exception of adequately treated in-situ carcinoma of the cervix, uteri, bladder, or nonmelanomatous skin cancer.
- •Active, uncontrolled infection(s) requiring systemic therapy, defined as ongoing signs/symptoms related to the infection without improvement despite appropriate treatment.
- •Severe, active co-morbidity, defined as follows:
- •Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
- •Transmural myocardial infarction within the 6 months of study registration
- •Uncontrolled hypertension, diabetes or arrhythmia.
- •Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization.
- •Not able to take medicine orally.
研究组 & 干预措施
chemotherapy
gemcitabine 1g/m2 iv d1, 8, 15, q4wks. 6 cycles.
干预措施: Gemcitabine (Drug)
chemotherapy with chemoradiation
gemcitabine 1g/m2 iv d1, 8, 15, q4wks. 6 cycles. Followed by TS-1 based chemoradiation. TS-1 40mg/m2 bid, 5 days/week, with radiation.
干预措施: Gemcitabine (Drug)
chemotherapy with chemoradiation
gemcitabine 1g/m2 iv d1, 8, 15, q4wks. 6 cycles. Followed by TS-1 based chemoradiation. TS-1 40mg/m2 bid, 5 days/week, with radiation.
干预措施: TS-1 with radiation (Radiation)
结局指标
主要结局
Disease free survival
时间窗: From date of randomization until the date of first documented disease recurrence or date of death from any cause, whichever came first, assessed up to 24 months
次要结局
- overall survival(From date of randomization until the date of death from any cause, assessed up to 36 months)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(from randomization to 1 month after end of treatment)
研究者
YueJuan Cheng
MD
Peking Union Medical College Hospital