NCT01531712

Study of Neoadjuvant Treatment in Patients With Pancreatic Cancer That is Potentially Resectable

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.

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Institut Català d'Oncologia · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Phase II study of neoadjuvant treatment with Gemcitabine, Tarceva and Oxaliplatin followed by chemotherapy with Tarceva and Gemcitabine in patients with pancreatic adenocarcinoma with borderline resectability. The primary objective is to determine the resectability rate of patients with pancreas adenocarcinoma with borderline resectability determined radiologically, treated with Gemcitabine, Tarceva and Oxaliplatin followed by radiotherapy with Gemcitabine and Tarceva.

Detailed description

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.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Gemcitabine	1000mg/m2 / / 40mg/m2
RADIATION	Radiotherapy	50.4 Gy
DRUG	Tarceva	100mg/day
DRUG	Oxaliplatin	100mg/m2 (only in QT)

Timeline

• Start date: 2011-02-10
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2012-02-13
• Last updated: 2017-08-29

Locations

1 site across 1 country: Spain