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临床试验/ACTRN12617001642370
ACTRN12617001642370进行中(未招募)2 期

Mfolfirinox And STEreotactic Radiotherapy for Patients with Locally Advanced paNcreatic cancer (MASTERPLAN Pilot): a feasibility study to assess if mFOLFIRINOX chemotherapy and Stereotactic Body Radiation Therapy (SBRT) is a feasible neoadjuvant treatment option with acceptable acute toxicity rates for patients with Borderline Resectable Pancreatic Adenocarcinoma (BRPC) or Unresectable Pancreatic Adenocarcinoma (UPC)

iverpool Hospital0 个研究点目标入组 11 人开始时间: 2017年12月19日最近更新:
适应症

试验速览

阶段
2 期
状态
进行中(未招募)
发起方
入组人数
11

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Non-randomised trial
主要目的
Treatment

入排标准

年龄范围
18 Years 至 70 Years(—)
性别
All

入选标准

  • Age greater than or equal to 18 years and able to give informed consent.
  • Patients with histologically confirmed adenocarcinoma of the pancreas that is classified as BRPC or UPC, as per NCCN guidelines.
  • ECOG performance status 0 or 1.
  • Adequate bone marrow function (absolute neutrophil count ((ANC) greater than 1.5, platelets greater than 100).
  • Adequate liver function (albumin greater than 25 g/L, bilirubin less than or equal to 26 micromol/L; transaminases (ALT/AST) less than or equal to 5 times the upper limit of normal (ULN)).
  • Adequate renal function (creatinine less than or equal to 1.5 times the ULN).

排除标准

  • Age 70 years and over.
  • Patients with resectable or metastatic pancreatic cancer.
  • Neuroendocrine pancreatic carcinoma.
  • Previous chemotherapy or abdominal radiotherapy.
  • Previous diagnosis of cancer within the last 5 years (excluding non-melanoma skin cancers, and carcinoma in situ).
  • Chronic diarrhoea or peripheral neuropathy equal to or greater than grade 2.
  • Non-controlled coronary artery disease or myocardial infarction within the last 6 months.
  • Known hypersensitivity to 5-fluorouracil, irinotecan, oxaliplatin, capecitabine.
  • Patient will be ineligible for fMRI if they have contraindication to MRI. They will still have other imaging performed (18FDG-PET and 18F-MISO).
  • Patients with portal hypertension, coagulopathy or an inaccessible portal vein will not have portal vein blood sampling done as part of CTC/cPSC sub-study.

研究者

发起方
iverpool Hospital

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