At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed adenocarcinoma of pancreatic head, uncinate process, body or tail
- ✓cTNM stage T1-4N0-2M0
- ✓Borderline resectable disease confirmed by multidisciplinary board using NCCN criteria on CT/MRI
- ✓Age >18 years
- ✕Extrapancreatic disease on imaging or at laparoscopy, including non-regional lymph node involvement and distant metastases
- ✕Locally advanced disease defined by >180° arterial encasement (SMA and CA) or unreconstructible venous encasement
- ✕CA 19.9 >2500 kU/l at baseline without cholestasis
- ✕Contraindication to surgery
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Preoperative Treatment With mFOLFIRINOX (or Gem-Nab-P) +/- Isotoxic High-dose Stereotactic Body Radiation Therapy (iHD-SBRT) for Borderline Resectable Pancreatic Adenocarcinoma: a Randomised Phase II Study (STEREOPAC)
In Brief
A Phase 2 clinical trial evaluating mFOLFIRINOX or Gemcitabine nab-paclitaxel, Isotoxic High-Dose (iHD)-SBRT, and 1 other intervention for Pancreatic Neoplasm and 2 related conditions. Currently recruiting, targeting 256 participants across 10 sites.
Signals
Detailed Summary
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.
Study Details
Timeline
Interventions
oxaliplatin IV, irinotecan IV, leucovorin IV and 5-FU IV OR Gemcitabine IV Nab paclitaxel
Radiation therapy
Surgery