- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02754180
Adjuvant Gemcitabine Versus Gemcitabine With Chemoradiation in Pancreatic Adenocarcinoma With R1 Resection and/or Positive Lymph Nodes
April 27, 2016 updated by: YueJuan Cheng, Peking Union Medical College Hospital
Adjuvant Gemcitabine Versus Gemcitabine With Chemoradiation in Pancreatic Adenocarcinoma With R1 Resection and/or Positive Lymph Nodes after curative resection.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
110
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Bai Chunmei, MD
- Phone Number: 861069158773
- Email: baichunmei1964@163.com
Study Contact Backup
- Name: Cheng Yuejuan, MD
- Phone Number: 861069158773
- Email: cnchengyuejuan@yahoo.com
Study Locations
-
-
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Beijing, China, 100730
- Recruiting
- Division of Medical Oncology, Peking Union Medical College Hospital
-
Contact:
- Yuejuan Cheng, M.D.
- Phone Number: 861069158315
- Email: cnchengyuejuan@yahoo.com
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Principal Investigator:
- Bai Chunmei, MD
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Sub-Investigator:
- Cheng Yuejuan, MD
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: chemotherapy
gemcitabine 1g/m2 iv d1, 8, 15, q4wks.
6 cycles.
|
gemcitabine 1g/m2 iv d1, 8, 15, q4wks.
6 cycles
Other Names:
|
Experimental: 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 1g/m2 iv d1, 8, 15, q4wks.
6 cycles
Other Names:
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Disease free survival
Time Frame: 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
|
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 Outcome Measures
Outcome Measure |
Time Frame |
---|---|
overall survival
Time Frame: From date of randomization until the date of death from any cause, assessed up to 36 months
|
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
Time Frame: from randomization to 1 month after end of treatment
|
from randomization to 1 month after end of treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2016
Primary Completion (Anticipated)
March 1, 2019
Study Completion (Anticipated)
March 1, 2021
Study Registration Dates
First Submitted
April 20, 2016
First Submitted That Met QC Criteria
April 27, 2016
First Posted (Estimate)
April 28, 2016
Study Record Updates
Last Update Posted (Estimate)
April 28, 2016
Last Update Submitted That Met QC Criteria
April 27, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Endocrine System Diseases
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Pancreatic Diseases
- Adenocarcinoma
- Pancreatic Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Gemcitabine
Other Study ID Numbers
- ZS-1015
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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