The Role of the Tumor Microenvironment of Pancreatic Cancer to Predict Treatment Outcome
Status:
Completed
Trial end date:
2017-12-01
Target enrollment:
Participant gender:
Summary
Pancreatic cancer is a highly lethal disease. Patients with resectable or borderline
resectable disease may benefit from preoperative radiochemotherapy. However, only a subset of
patients will respond to this potentially toxic and expensive treatment. Therefore, novel
predictive markers are needed to determine treatment efficacy at an early stage. Preferably,
these markers could be determined non-invasively and provide insight into the biology of
pancreatic cancer. Pancreatic cancers are heterogeneous tumors. The tumor microenvironment is
often characterized by large amounts of stroma, hypovascularization, and hypoxia. As these
three factors can all contribute to treatment resistance, a quantitative assessment of these
markers may aid in the prediction of response to preoperative radiochemotherapy. Moreover,
these assessments may have prognostic value. Finally, further insight into the interrelation
of these aspects of the tumor microenvironment can contribute to the evaluation of new
targeted treatment options. Tumor cellularity and extracellular matrix composition can be
assessed non-invasively in vivo by diffusion weighted magnetic resonance imaging (DWI) and
tumor vascularity can be assessed by dynamic contrast enhanced magnetic resonance imaging
(DCE-MRI). Finally, tumor hypoxia can be evaluated by T2* MRI and PET-CT, using the
18F-labeled hypoxic marker HX4.
Objective of the study:
The primary aim of the study is to assess whether DWI, DCE-MRI, T2*, and 18F-HX4-PET/CT
predict overall survival in patients with pancreatic cancer treated with surgery and adjuvant
chemotherapy or with neoadjuvant radiochemotherapy, surgery and adjuvant chemotherapy.
Secondary aims of the study include the assessment of the predictive value of DWI, DCE-MRI,
T2*, and 18F-HX4-PET/CT for pathological response to neoadjuvant chemoradiation, the
correlation of DWI, DCE-MRI, T2*, and 18F-HX4-PET/CT with histopathological assessment of
tumor stroma, vascularization, and hypoxia, and the assessment of the predictive value of
these histopathological markers for overall survival.
Phase:
N/A
Details
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)