Preoperative treatment with mFOLFIRINOX (or Gem-Nab-P) +/- isotoxic high-dose Stereotactic Body Radiation Therapy (iHD-SBRT) for borderline resectable pancreatic adenocarcinoma: a randomised comparative multicentre phase II study (STEREOPAC) - STEREOPAC-001

Hopital Erasme0 个研究点目标入组 256 人开始时间: 2022年8月10日最近更新: 2024年7月22日

适应症

试验速览

暂无简介。

•Cytologic or histologic proof of adenocarcinoma of the pancreatic head or uncinated process , body or tail. Diagnosis should be verified by local pathologist., cTNM stage: T1-4 N0-2 M0, Confirmation of clinical and radiographic stage as borderline resectable determined centrally by review of a diagnostic multisliced triphasic CT scan and/or MRI with contrast by a multidisciplinary board composed of a dedicated oncological surgeon, radiologist and GI oncologist, No prior chemotherapy or radiation for pancreatic cancer unless the neoadjuvant regimen as described, Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, No grade = 2 neuropathies, Laboratory parameters as follows: Absolute neutrophil count (ANC) = 1,500/mm3, Platelet count = 100,000/mm3, Hemoglobin = 9 g/dL, Creatinine = 1.5 x upper limit of normal (ULN) or estimated GFR > 45 mL/min, Bilirubin = 1.5 x ULN including after adequate biliary stenting with metal stent (ideally 4 cm length), Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) = 2.5x ULN, CA 19.9 < 2500 kU/l (baseline and absence of cholestasis)

•Evidence of extrapancreatic disease on diagnostic imaging (CT, MRI, or PET scan), or laparoscopy, including distal nodal involvement beyond the peripancreatic tissues and/or distant metastases, Uncontrolled pre-existing disease including, but not limited to: active infection, symptomatic congestive heart failure, unstable angina, social / psychiatric disorder that would limit compliance to treatment and good understanding of the informed consent form, Chronic concomitant treatment with strong inhibitors of cytochrome p450, family 3, subfamily a, polypeptide 4 gene (CYP3A4) is not allowed on this study; patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to inclusion in the study., Unresectable disease as defined by the NCCN criteria, ie > 180° arterial encasement (SMA), unreconstructible or fully thrombosed venous invasion, CA 19.9 > 2500 kU/l (baseline, prior neoadjuvant therapy and absence of cholestasis), Contraindication of surgery (general), Contraindications to receive mFFX or Gem-Nab-P, History of radiotherapy of the upper abdomen, Prior treatment with oxaliplatin, irinotecan, 5-FU or capecitabin for PDAC, Complete DPD deficiency, Major surgery within 4 weeks of study entry

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