Status:
UNKNOWN
Adjuvant Gemcitabine Versus Gemcitabine With Chemoradiation in Pancreatic Adenocarcinoma With R1 Resection and/or Positive Lymph Nodes
Lead Sponsor:
Peking Union Medical College Hospital
Conditions:
Pancreatic Neoplasms
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2021
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT02754180
Start Date
March 1 2016
End Date
March 1 2021
Last Update
April 28 2016
Active Locations (1)
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1
Division of Medical Oncology, Peking Union Medical College Hospital
Beijing, China, 100730