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Source: isrctn - Le promoteur: Ruprecht-Karls-University Heidelberg (Germany)
Ruprecht-Karls-University Heidelberg (Germany) MAJ Il y a 4 ans

STEM PACE - Stem cell Transplantation for Eradication of Minimal PAncreatic cancer persisting after surgical Excision Background and study aims Pancreatic cancer is the third most common cancer related cause of death. Even in the 15% of patients who are eligible for surgical resection, less than 10% of patients surviving after 5 years. Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is an established treatment capable of curing a variety of hematopoietic malignancies, taking advantage of the graft-versus-tumor effect (GVT). It works best when the underlying neoplasm has been turned into a stage of minimal disease by chemotherapy. There have been attempts of applying allo-HSCT to advanced solid tumors including pancreatic cancer with limited success but studies of allo-HSCT in solid tumors in minimal disease situations have never been performed. The aim of this study is to provide evidence for the clinical value of allo-HSCT in pancreatic cancer put into a minimal disease status by effective surgical resection and standard adjuvant chemotherapy. We want to find out if allo-HSCT can change the unfavourable natural course of this disease and whether allo-HSCT is able to provide long-term disease control to an extent otherwise not possible in pancreatic cancer and improve survival of affected patients. Who can participate? Patients with histologically proven diagnosis of pancreatic ductal adenocarcinoma having undergone radical resection (R1/R0 local resection) within the last 4-6 months at the University Hospital Heidelberg, who are matching the inclusion criteria. What does the study involve? Patients will undergo conditioning for allo-HSCT (fludarabine 30mg/mE2/d d -6 through d -2, cyclophosphamide 60mg/kg/d d-3 and d -2) followed by transplantation of allogeneic unmanipulated peripheral blood stem cells on d 0. Standard GVHD prophylaxis with CSA (target level 150-200; start d -1, taper d +60 onwards in the absence of GVHD) and MMF (2x1g; start d 0, stop d +30 in the absence of acute GVHD) will be instituted. What are the possible benefits and risks of participating? Not provided at time of registration Where is the study run from? Clinic of General Surgery, Heidelberg (Germany) When is the study starting and how long is it expected to run for? From May 2012 to June 2016 Who is funding the study? Heidelberg Surgery Foundation, University of Heidelberg (Germany) Who is the main contact? Klinisches Studienzentrum der Chirurgie (KSC) [email protected]

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