Adjuvant Gemcitabine Versus Gemcitabine With TS-1 based Chemoradiation in Pancreatic Adenocarcinoma With R1 Resection and/or Positive Lymph Nodes after curative resection: a randomized phase II study.
Subject should start treatment no later than 10 weeks postsurgery.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Acceptable hematology parameters:
* Absolute neutrophil count ≥1500 cell/mm3
* Platelet count ≥100,000/mm3
* Hemoglobin (Hgb) ≥8.0 g/dL
Acceptable blood chemistry levels:
* Aspartate aminotransferase (AST) and Alanine transaminase (ALT) ≤2.5 × upper limit of normal range (ULN)
* Total bilirubin ≤ 2.5 x upper Limit of Normal (ULN)
* Serum creatinine within upper limits of normal.
Cancer antigen (CA)19-9 ≤ 2.5 x upper Limit of Normal (ULN) assessed within 14 days of randomization.
No disease recurrence or metastases detected on CT/MRI assessed within 30 days of randomization.
Signed informed consent.
You may not be if
R2 resection or presence of metastatic disease.
Prior neo-adjuvant treatment or radiation therapy for pancreatic adenocarcinoma.
Any other malignancy within 5 years prior to randomization, with the exception of adequately treated in-situ carcinoma of the cervix, uteri, bladder, or nonmelanomatous skin cancer.
Active, uncontrolled infection(s) requiring systemic therapy, defined as ongoing signs/symptoms related to the infection without improvement despite appropriate treatment.
Severe, active co-morbidity, defined as follows:
* Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
* Transmural myocardial infarction within the 6 months of study registration
* Uncontrolled hypertension, diabetes or arrhythmia.
* Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization.
