2022-501181-22-01招募中2 期
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)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 256
- 试验地点
- 17
- 主要终点
- Residual tumour (R)0 resection
研究概览
简要总结
The primary objective is to compare R0 resection (> 1 mm) and DFS (as co-primary endpoint) in arm A (‘standard’-chemotherapy) to arm B (‘experimental’-chemotherapy + SBRT) in an intention-to-treat analysis.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Residual tumour (R)0 resection
Residual tumour (R)0 resection
Disease-free-survival
Disease-free-survival
次要结局
- Resection rate
- Locoregional failure free interval
- Distant metastases free interval
- Toxicity, Incidence of adverse events
- Complete feasibility of the therapeutic sequence
- Overall survival
- Pathologic complete/major response rate (pCR)
- Quality of life assessment
- Postoperative complications rate
- Technical and quality success rate of EUS-delivered fiducials
研究者
Jean-Luc Van Laethem
Scientific
Hopital Erasme
研究点 (17)
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