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2022年2月3日
概览
- 阶段
- 2 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Pancreatic ductal adenocarcinoma
- 发起方
- Kobayashi Shogo
- 入组人数
- 70
- 状态
- 招募中
- 最后更新
- 2年前
概览
简要总结
暂无简介。
研究者
入排标准
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
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,
结局指标
主要结局
未指定
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