Adjuvant Gemcitabine Versus Gemcitabine With Chemoradiation in Pancreatic Adenocarcinoma With R1 Resection and/or Positive Lymph Nodes
NCT ID: NCT02754180
Last Updated: 2016-04-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
110 participants
INTERVENTIONAL
2016-03-31
2021-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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chemotherapy
gemcitabine 1g/m2 iv d1, 8, 15, q4wks. 6 cycles.
Gemcitabine
gemcitabine 1g/m2 iv d1, 8, 15, q4wks. 6 cycles
chemotherapy with chemoradiation
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.
Gemcitabine
gemcitabine 1g/m2 iv d1, 8, 15, q4wks. 6 cycles
TS-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.
Interventions
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Gemcitabine
gemcitabine 1g/m2 iv d1, 8, 15, q4wks. 6 cycles
TS-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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
Yes
Sponsors
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Peking Union Medical College Hospital
OTHER
Responsible Party
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YueJuan Cheng
MD
Locations
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Division of Medical Oncology, Peking Union Medical College Hospital
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ZS-1015
Identifier Type: -
Identifier Source: org_study_id
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