Status:
COMPLETED
A Phase III Study of Pancreatic Cancer
Lead Sponsor:
National Health Research Institutes, Taiwan
Collaborating Sponsors:
National Taiwan University Hospital
Chang Gung Memorial Hospital
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
20-75 years
Brief Summary
Study Design： Adjuvant gemcitabine therapy has been shown to improve recurrence-free survival in pancreatic cancer underwent curative intent resection. This study is to evaluate whether combining conc...
Detailed Description
Treatment plan and Randomization scheme:： Patients will be randomized after stratification according to pathology report on section margin, tumor size, lymph node metastasis: Patients who are random...
Eligibility Criteria
Inclusion
- A.Eligibility Criteria
- Patients with pancreatic cancer after curative intent resection.
- The histology of resected tumor has to be adenocarcinoma.
- Age 20-75 years.
- ECOG performance scale 0-1.
- Patients must have normal organ and marrow function as defined below.
- The effects of study agents on the developing human fetus at the recommended therapeutic dose are unknown.
- to sign a written informed consent.
- Registered within 6 weeks after surgery.
- Preoperative abdominal CT or MRI with contrast enhancement.
- B.Exclusion Criteria
- Patients with gross residual, macroscopic positive resection margin or distant metastases.
- Patients may not be receiving any other investigational agents.
- Patients who have had prior chemotherapy or radiotherapy are not eligible.
- History of allergic reactions.
- Patients who had non-curable second primary malignancy.
- Uncontrolled intercurrent illness including.
- Pregnant women.
- receiving immuno-suppressive therapy、anti-coagulants.
Exclusion
Key Trial Info
Start Date :
February 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
147 Patients enrolled
Trial Details
Trial ID
NCT00994721
Start Date
February 1 2009
End Date
January 1 2016
Last Update
May 4 2016
Active Locations (3)
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1
Chang-Gung Memorial Hospital
Taipei, Taiwan
2
Mackay Memorial Hospital
Taipei, Taiwan
3
National Taiwan University Hospital
Taipei, Taiwan