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A Phase III Study of Pancreatic Cancer

NCT00994721 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 147

Last updated 2016-05-04

No results posted yet for this study

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 concurrent chemo-radiotherapy can further improve the recurrence-free survival benefit of adjuvant gemcitabine chemotherapy in pancreatic cancer underwent curative resection.

Research Objective and Study End Points

1. Primary endpoint： The primary end point is disease free survival.
2. Secondary endpoints： The secondary end points are to evaluate the overall survival, local and distant recurrence rate, and impact on quality of life after adjuvant gemcitabine with or without CCRT in curatively resected pancreatic cancer.

Furthermore, the clinical, pathological and molecular prognostic factors in curatively resected pancreatic cancers will be evaluated.

Conditions

Sponsors & Collaborators

  • National Taiwan University Hospital

    collaborator OTHER

  • Chang Gung Memorial Hospital

    collaborator OTHER

  • Taipei Veterans General Hospital, Taiwan

    collaborator OTHER_GOV

  • Mackay Memorial Hospital

    collaborator OTHER

  • Taichung Veterans General Hospital

    collaborator OTHER

  • National Cheng-Kung University Hospital

    collaborator OTHER

  • Kaohsiung Veterans General Hospital.

    collaborator OTHER

  • Kaohsiung Medical University

    collaborator OTHER

  • National Health Research Institutes, Taiwan

    lead OTHER

Principal Investigators

  • Tsann-Long Hwang, M.D. · Chang Gung Memorial Hospital

  • Yu-Wen Tien Tien, Ph.D. · National Taiwan University Hospital

  • Yi-Ming Shyr, M.D. · Taipei Veterans General Hospital, Taiwan

  • Pin-Wen Lin, M.D · National Cheng-Kung University Hospital

  • Yu-Lin Lin, M.D. · National Taiwan University Hospital

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • Taiwan

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00994721 on ClinicalTrials.gov