Phase II Study of Neoadjuvant Treatment With Gemcitabine, Tarceva and Oxaliplatin Followed by Chemotherapy With Tarceva and Gemcitabine in Patients With Pancreas Adenocarcinoma With Borderline Resectability.
Patients with borderline resectable pancreatic adenocarcinoma are more likely to develop
perioperative complications due to the complexity of surgery. In these patients there is
also an increased risk of systemic relapse due to the advanced stage of the tumor as well as
a higher possibility of having positive margins. Therefore, the treatment of these patients
need to be decided based on a multidisciplinary strategy. Besides of that the use of
systemic neoadjuvant chemotherapy as induction therapy, followed by sequential
chemoradiotherapy is a very attractive therapeutic modality.
The neoadjuvant treatment offers the potential advantages of reducing the tumor stage,
increasing resectability and decreasing postoperative complications.
The administration of chemotherapy and radiotherapy before surgery represent an strategy for
early treatment of micrometastatic disease, present in most of these patients, and to
identify patients with rapid progression of the disease.
For all the reasons above, the investigators consider it's of great interest to design new
studies that combine systemic neoadjuvant chemotherapy followed by chemoradiotherapy with
neoadjuvant intention in patients with pancreas cancer locally advanced.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Resectability rate after neoadjuvant treatment with chemotherapy plus chemoradiotherapy.
Determine the resectability rate of subjects with borderline resectable pancreatic cancer (radiologically measured) that were treated with Gemcitabine, Tarceva and Oxaliplatin followed by chemoradiotherapy with Gemcitabine and Tarceva.
Berta Laquente, MD
Spain: Spanish Agency of Medicines