JPRN-jRCTs051210167招募中2 期
The survival benefit of chemoradiation (Gem/nab-PTX+RT) followed by conversion surgery in patients with unresectable locally advanced pancreatic cancer: multicenter randomized phase II trial
Kobayashi Shogo0 个研究点目标入组 70 人开始时间: 2022年2月3日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Inclusion criteria
- •(1) Histological or cytological evidence of pancreatic ductal carcinoma
- •(2) Age>=20
- •(3) PS:0-1(ECOG grade)
- •(4) Patients with unresectable locally advanced pancreatic ductal carcinoma at the first visit, which are diagnosed as being able to undergo conversion surgery after Gemcitabine+nab-paclitaxel therapy
- •The criteria of unresectable locally advanced cancer
- •1)Solid tumor contact with the SMA or CA > 180deg
- •2)Solid tumor contact with the CA and aortic involvement
- •3)Unreconstructible SMV/PV due to tumor involvement or occlusion
- •The criteria of conversion surgery
- •1) The serum tumor marker (CEA, CA19-9) is within normal range
- •2) Imagings of computed tomography (less than 5mm slice) meet the following criteria
- •i) no metastasis
- •ii) No tumor contact with the SMV or PV.
- •Solid tumor contact with the SMV or PV with suitable vessel proximal and distal to the site of involvement allowing for safe and complete resection and vein reconstruction
- •iii) In pancreatic head/uncinate, no arterial tumor contact (CA, SMA, CHA). Solid tumor contact with CHA without extension to CA or hepatic artery bifurcation allowing for safe and complete resection and reconstruction. Solid tumor contact with the SMA of <180deg
- •iv) In the pancreatic body/tail, solid tumor contact with the CA of <180deg. Solid tumor with the CA of >180deg without the involvement of aorta and with intact and uninvolved
- •Even if the above criteria are not met, conversion surgery is possible when there is no abnormal accumulation of FDG at PET-CT, or at biopsy there are not malignant findings, conversion surgery was possible.
- •(5) Patients with the normal function of principle organs (bone marrow, liver, kidney, lung, etc)
- •Leukocyte >=3,500/mm3
- •Neutrocyte >=2,000/mm3
- •Platelet >=100,000/mm3
- •Hemogrobin >=9.0g/dl
- •Total bilirbin <=2.0mg/dl (or <=3.0mg/dl in patients with intervention for obstruction jaundice)
- •AST (GOT), ALT (GPT)<=150U/L
- •Serum creatinine <=1.5mg/dl
- •Creatinine clearance >=60ml/min (according to Cockroft-Gault calculating formula)
- •(6) Acquisition of written informed consent
排除标准
- •Exclusion criteria
- •(1) Unresectable pancreatic ductal carcinoma with the following imaging criteria
- •1)no distant metastasis
- •2)no peritoneal dissemination, positive cytology
- •3)no para-aortic lymph node metastasis
- •(2) Patients with tumor involvement in organs that are difficult to treat with radiation
- •(3) Patients with anamnesis of pulmonary fibrosis or emphysema, or patients with severe respiratory d disability
- •(for example,%VC<=50% or FW|EV1.0<1L)
- •(4) Patients with active infection except for viral hepatitis
- •(5) Patients with severe general complications, for example, cardiac failure, renal failure, hepatic failure,
- •uncontrolled diabetes, etc.
- •(6) Patients with a moderate amount of ascites or pleural effusion
- •(7)Patients with active double cancer (synchronous or metachronous with a disease-free period of 3 years or less)
- •(8) Patients in pregnancy, patients in possible pregnancy, patients which wish to be in pregnancy, patients with breastfeeding, a male which wishes that his partner is to be in pregnancy
- •(9) Patients with severe mental disability
- •(10) Patients with severe drug-induced hypersensitivity syndrome
- •(11) Patients who are judged inappropriate for entry into this study by the investigators
研究者
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