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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)
EU CTIS ID: 2022-501181-22-01
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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)
See the full eligibility criteria
- 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 (patients with complete DPD deficiency can be included and started on Gem-Nab if all other inclusion and exclusion criteria are met)
- Major surgery within 4 weeks of study entry
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.