OncoMatch/Clinical Trials/NCT05083247
Preoperative mFOLFIRINOX (or Gem-Nab-P) +/- Isotoxic High-dose SBRT for Borderline Resectable Pancreatic Adenocarcinoma
Is NCT05083247 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies mFOLFIRINOX or Gemcitabine nab-paclitaxel for pancreatic neoplasm.
Treatment: mFOLFIRINOX or Gemcitabine nab-paclitaxel — Surgical resection is the only potentially curative treatment for patients with pancreatic cancer with the aim of curative R0 resection and related improvement of survival. As a standard, surgery is usually followed by adjuvant therapy that improves survival but neoadjuvant therapy (NAT) is a rapidly emerging concept that needs to be explored and validated in terms of therapeutic options in borderline resectable pancreatic tumors. In this setting, preoperative FFX seems to be feasible and can be prolonged by radiation therapy. However, the exact and best therapeutic sequence is not yet known and the additional role of adding isotoxic high-dose stereotactic body radiotherapy (iHD-SBRT) to chemotherapy requires validation in randomised trials. We propose to evaluate the impact and efficacy of adding iHD-SBRT to preoperative neoadjuvant mFFX or Gem-NabP in patients with borderline resectable pancreatic adenocarcinoma.
Check if I qualifyExtracted eligibility criteria
Cancer type
Pancreatic Cancer
Disease stage
Required: Stage T1-4N0-2M0 (cTNM)
cTNM stage: T1-4N0-2M0; Confirmation of clinical and radiographic stage as borderline resectable (CT scan and/or MRI scan with contrast according to the NCCN criteria)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: chemotherapy
No prior chemotherapy or radiation for pancreatic cancer
Cannot have received: radiation therapy
No prior chemotherapy or radiation for pancreatic cancer
Cannot have received: oxaliplatin (oxaliplatin)
Prior treatment with oxaliplatin, irinotecan, fluoruouracil or capecitabin
Cannot have received: irinotecan (irinotecan)
Prior treatment with oxaliplatin, irinotecan, fluoruouracil or capecitabin
Cannot have received: antimetabolite (fluorouracil, capecitabin)
Prior treatment with oxaliplatin, irinotecan, fluoruouracil or capecitabin
Cannot have received: radiation therapy
History of radiotherapy of the upper abdomen
Cannot have received: other anticancer therapies
Other concurrent anticancer therapies
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥ 1,500/mm³; Platelet count ≥ 100,000/mm³; Hemoglobin ≥ 9 g/dL
Kidney function
Creatinine ≤ 1.5 x ULN or estimated GFR >45 mL/min
Liver function
Bilirubin ≤ 1.5 x ULN, including after adequate biliary stenting with metal stent (ideally 4 cm length); AST/ALT ≤ 2.5x ULN
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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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