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 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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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.|
- Resectability rate after neoadjuvant treatment with chemotherapy plus chemoradiotherapy. [ Time Frame: Two years ] [ Designated as safety issue: No ]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.
- Median overall survival. [ Time Frame: Two years ] [ Designated as safety issue: No ]To determine the overall survival (OS) and the tumor recurrence pattern (local versus distant).
- Rate of resections with engative margins and complete pathological response. [ Time Frame: Two years ] [ Designated as safety issue: No ]To determine the rate of negative margin resections and complete pathological response (cPR).
- Response rate to neoadjuvant treatment of tumor markers (CEA, CA19-9) [ Time Frame: Two years ] [ Designated as safety issue: No ]To determine the reponse rate to the neoadjuvant treatment of speficic tumor markers (CEA, Ca19-9).
- Ratio of objective responses (RECIST). [ Time Frame: Two years ] [ Designated as safety issue: No ]To determine the ratio of objective responses according to RECIST criteria.
- Prognosis accuracy of serum protein profiles [ Time Frame: Two years ] [ Designated as safety issue: No ]To determine the prognosis accuracy of serum protein profiles in these subjects.
- Viability of the collection of pre-treatment tumor samples [ Time Frame: Two years ] [ Designated as safety issue: No ]To determine the feasibility of the collection of pre-treatment (baseline) tumor samples and to set pathological correlations with the response after neoadyuvant treatment.
- Adverse events [ Time Frame: Two years ] [ Designated as safety issue: Yes ]To determine the safety, toxicity and feasibility of this therapeutical regimen as neoadyuvant treatment.
|Study Start Date:||July 2011|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Experimental: QT + QRT
Chemotherapy (6 cycles x 14 days): Gemcitabine 1000 mg/m2 (day 1) + Oxaliplatin 100 mg/m2 (day 2) + Tarceva 100 mg/day.
Chemoradiotherapy (5,5 weeks): Gemcitabine 40 mg/m2 (2 days/week) + Tarceva 100 mg/day + Radiotherapy (1,8 Gy/day x 28 doses, total dose: 50,4 Gy).
1000mg/m2 / / 40mg/m2
Other Name: gemzarRadiation: Radiotherapy
50.4 GyDrug: Tarceva
Other Name: ErlotinibDrug: Oxaliplatin
100mg/m2 (only in QT)
Other Name: ELOXATIN
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.