Gemcitabine and Capecitabine With or Without T-ChOS as Adjuvant Therapy for Patients With Resected Pancreatic Cancer

Exclusion Criteria

• •1. Prior neo-adjuvant treatment, radiation therapy, or systemic therapy for pancreatic adenocarcinoma
• •2. Presence of or history of metastatic or locally recurrent pancreatic adenocarcinoma
• •3. Other malignancies, except adequately treated basal carcinoma or squamous cell carcinoma of the skin or in situ cervix carcinoma or incidental prostate cancer (T1a, Gleason score ≤ 6, PSA \< 0.5 ng/ml), or any other tumor with a DSF survival of ≥ 5 years
• •4. History of serious or concurrent illness or uncontrolled medical disorder; any medical condition that might be aggravated by chemotherapy treatment or which could not be controlled; including, but not restricted to:
• •* Active infection requiring antibiotics within 2 weeks before the study inclusion
• •* Concurrent congestive heart failure NYHA class III - IV
• •* Unstable angina pectoris, or myocardial infarction within 6 months and/or prior poorly controlled hypertension
• •* History of interstitial lung disease, slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies
• •* Concomitant use of immunosuppressive or myelosuppressive medications that would in the opinion of the investigator, increase the risk of serious neutropenic complications
• •5. Known or suspected allergy to the investigational agents or any agents given in association with this trial
• •6. Any psychological, familial, sociological, or geographical condition which does not permit protocol compliance and medical follow-up
• •7. Enrollment in any other clinical protocol or investigational study with an interventional agent or assessments that may interfere with study procedures
• •8. Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
• •9. Any condition that confounds the ability to interpret data from the study
• •10. Unwillingness or inability to comply with study procedures
• •11. Current use of anticoagulation therapy such as heparins both unfractionated and low molecular weighted