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Adjuvant Gemcitabine Versus Gemcitabine With Chemoradiation in Pancreatic Adenocarcinoma With R1 Resection and/or Positive Lymph Nodes after curative resection.
Full 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.
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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:
Acceptable blood chemistry levels:
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:
Not able to take medicine orally.
Primary purpose
Allocation
Interventional model
Masking
110 participants in 2 patient groups
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Central trial contact
Bai Chunmei, MD; Cheng Yuejuan, MD
Data sourced from clinicaltrials.gov
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