This is a Phase II open study, not randomized with a neoadjuvant therapy,combination of Gemcitabine (1,000 mg/m2/week) with Erlotinib (100mg/day) (3 cycles of 4 weeks), followed by gemcitabine (300 mg/m2/week) combined with Erlotinib (100mg/day) and radiotherapy (45 Gy / day fr180 cGy) (5 cycles of 1 week) in patients with resectable pancreatic adenocarcinoma to assess the percentage of R0 resections. They have planned a total of 21 visits.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Administration of gemcitabine (300mg/m2/weekly)with Erlotinib (100 mg/daily) and radiotherapy (45 Gy/daily) after a period of infusion with a full dose of Gemcitabine (1.000mg/m2/weekly) and Erlotinib (100 mg/daily)
Clínica Universitaria de Navarra
Pamplona, Navarre, Spain
Hospital del Mar
Barcelona, Spain
Institut Català d'Oncologia (ICO) de L'Hospitalet
Barcelona, Spain
Hospital Vall d'Hebron
Percentage of ancients undergoing with neoadjuvant chemoradiotherapy and R0 resection
Time frame: 3 years
To describe the safety of the treatment
Based in safety population, all safety parameters will be analyzed and they will be recorded in lists and spread sheets. Most extreme intensity will be used for the notification of adverse events. Safety population will include all subjects that have taken at least one study medication dose.
Time frame: 3 years
Evaluate the response rate using RECIST criteria
Time frame: 3 years
Evaluate the percentage of resectability
Time frame: 3 years
Evaluate the percentage of lymphatic nodes removed
Time frame: 3 years
Evaluate the percentage of lymphatic nodes involved
Time frame: 3 years
Evaluate the pathological regression stage (primary tumor and lymphatic nodes)
Time frame: 3 years
Relate RECIST criteria with the pathological regress stage
Time frame: 3 years
Measure the progression free survival (time from the inclusion date to the progression of the disease or death)
Time frame: 3 years
Evaluate the overall survival time
Time frame: 3 years
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Barcelona, Spain
Hospital Clínic de Barcelona
Barcelona, Spain
Hospital Santa Creu y Sant Pau, Hospital Sant Pau
Barcelona, Spain
Instituto Catalán de Oncología
Girona, Spain
Hospital Virgen de la Arrixaca
Murcia, Spain
Hospital la Fe de Valencia
Valencia, Spain
Clínico Universitario de Valencia
Valencia, Spain