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)
- Conditions
- Pancreatic adenocarcinomaTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- CTIS2022-501181-22-01
- Lead Sponsor
- Hopital Erasme
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 256
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 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.;Secondary Objective: Resection rate, Overall Survival, Locoregional failure free interval, Distant metastases free interval, Complete feasibility of the therapeutic sequence, Pathologic complete response rate, Toxicity (early and late), Postoperative complications rate, Quality of life (QoL) assessment, Technical and quality success rate of EUS-delivered fiducials;Primary end point(s): Residual tumour (R)0 resection, Disease-free-survival
- Secondary Outcome Measures
Name Time Method Secondary end point(s):Resection rate;Secondary end point(s):Locoregional failure free interval;Secondary end point(s):Distant metastases free interval;Secondary end point(s):Toxicity, Incidence of adverse events;Secondary end point(s):Complete feasibility of the therapeutic sequence;Secondary end point(s):Overall survival;Secondary end point(s):Pathologic complete/major response rate (pCR);Secondary end point(s):Quality of life assessment;Secondary end point(s):Postoperative complications rate;Secondary end point(s):Technical and quality success rate of EUS-delivered fiducials