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Clinical Trial Record

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Adjuvant Gemcitabine and Cisplatin Followed by Chemoradiation for Resected Pancreatic Cancer

2004-12

2011-06

2011-06

70

Study Overview

Adjuvant Gemcitabine and Cisplatin Followed by Chemoradiation for Resected Pancreatic Cancer

This is a phase Ⅱ Trial of Postoperative Adjuvant Gemcitabine and Cisplatin Chemotherapy Followed by Chemoradiation With Gemcitabine in Patients With Resected Pancreatic Cancer.

The primary study objective is to evaluate recurrence/metastasis free survival at 12 months with postoperative adjuvant treatment incorporating gemcitabine plus cisplatin chemotherapy followed by chemoradiation with gemcitabine followed by maintenance chemotherapy with gemcitabine.

  • Pancreatic Cancer
  • DRUG: gemcitabine and cisplatin
  • H-0412-138-006

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 Registration Dates Results Reporting Dates Study Record Updates

2011-07-01  

N/A  

2011-07-15  

2011-07-15  

N/A  

2011-07-19  

2011-07-19  

N/A  

2011-07  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
Primary Outcome MeasuresMeasure DescriptionTime Frame
recurrence/metastasis free survival24 months
Secondary Outcome MeasuresMeasure DescriptionTime Frame
2 year survival rate24 months
Overall survival24 months
recurrence free survivalMedian recurrence free survival time24 months
Safety and tolerabilitypatients who experienced grade 3-4 toxicity by RECIST criteria24 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    Inclusion Criteria:
    1. Give written informed consent prior to study specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice. 2. Be between 18 and 75 years of age. 3. Patients who are ambulatory and have a ECOG Performance Status of 0-2. 4. Histologically confirmed pancreatic adenocarcinoma. 5. Received curative resection (R0 resection) of stage 1b ~ 2b pancreatic cancer (according to AJCC staging, 6th edition - Appendix 1), no more than 8 weeks has elapsed since the time of operation. 6. WBC at least 3,000/mm3 OR Absolute neutrophil count at least 1,500/mm3. Platelet count at least 100,000/mm3. 7. Bilirubin less than 2.0 mg/dL, AST less than 3 times upper limit of normal (ULN).
    Serum creatinine no greater than 1.5 times ULN.
    Exclusion Criteria:
    1. Pregnant or lactating woman. 2. Woman of childbearing potential with either a positive or no pregnancy test at baseline. 3. Woman of childbearing potential not using a reliable and appropriate contraceptive method (postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential). 4. Sexually active males unwilling to practice contraception during the study. 5. Prior chemotherapy for the treatment of pancreatic carcinoma. 6. Radiotherapy incorporating radiation fields of more than 25% of active bone marrow. 7. History of another malignancy within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix. 8. Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease, and cardiac arrhythmias not well controlled with medication). 9. Participation in any investigational drug study within four weeks preceding the start of study treatment. 10. Serious, uncontrolled, intercurrent infection(s). 11. Other significant medical conditions that would, in the judgment of the investigator, make administration of study drug unsafe.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

    • PRINCIPAL_INVESTIGATOR: Seock-Ah Im, MD, PhD, Seoul National University Hospital

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    No publications available

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