Pancreatic Neoplasms
Conditions
Keywords
adjuvant, pancreatic cancer, R1 resection, positive lymph nodes
Brief summary
Adjuvant Gemcitabine Versus Gemcitabine With Chemoradiation in Pancreatic Adenocarcinoma With R1 Resection and/or Positive Lymph Nodes after curative resection.
Detailed description
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.
Interventions
DRUGGemcitabine
gemcitabine 1g/m2 iv d1, 8, 15, q4wks. 6 cycles
RADIATIONTS-1 with radiation
gemcitabine 1g/m2 iv d1, 8, 15, q4wks. 6 cycles. Followed by TS-1 based chemoradiation. TS-1 40mg/m2 bid, 5 days/week, with radiation.
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Histologically confirmed resected ductal pancreatic adenocarcinoma with R1 resection and/or positive lymph nodes. * 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.
Exclusion criteria
* 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. * Not able to take medicine orally.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease free survival | From date of randomization until the date of first documented disease recurrence or date of death from any cause, whichever came first, assessed up to 24 months |
Secondary
| Measure | Time frame |
|---|---|
| overall survival | From date of randomization until the date of death from any cause, assessed up to 36 months |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | from randomization to 1 month after end of treatment |
Countries
China
Contacts
Primary ContactBai Chunmei, MD
Backup ContactCheng Yuejuan, MD
Outcome results
None listed