A Randomized Phase III Study of Adjuvant Gemcitabine Versus Gemcitabine Plus Concurrent Chemoradiation in Pancreatic Cancer Underwent Curative Intent (R0 / R1) Resection
Sponsor study identifier
observational
147
1 country
3
Study Start
February 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2016
Actual (reported)Study Completion
January 2016
Actual (reported)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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2016
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 26, 2008
Actual (reported)February 2009
Date type not reportedThis date has not been verified as actual or estimated.
October 14, 2009
Actual (reported)January 2016
Actual (reported)January 2016
Actual (reported)The primary end-point is recurrence-free survival.
Pancreatic Cancer Disease Committee
The secondary end-points are overall survival; local and distant control rate, and the quality of life.
Pancreatic Cancer Disease Committee
resected pancreatic cancer
We anticipate the 2-year disease free survival will increase from 25% to 40% with the incorporation of CCRT into the adjuvant treatment for post-operative pancreatic andenocarcinoma. With a significant level of 0.05,107 patients will be required for each treatment arm to reach 80% statistical power. Since the drop out rate is approximately 10%, 265 patients will be enrolled to ensure that we will have 214(107x2) eligible patients in this study. We anticipate that we will recruit roughly 67 patients per year, therefore, patient recruitment will be completed in 4 years.
Chang-Gung Memorial Hospital
Taipei, Taiwan
Mackay Memorial Hospital
Taipei, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Chiu YF, Liu TW, Shan YS, Chen JS, Li CP, Ho CL, Hsieh RK, Hwang TL, Chen LT, Ch'ang HJ; Taiwan Cooperative Oncology Group pancreatic cancer study group. Carbohydrate Antigen 19-9 Response to Initial Adjuvant Chemotherapy Predicts Survival and Failure Pattern of Resected Pancreatic Adenocarcinoma but Not Which Patients Are Suited for Additional Adjuvant Chemoradiation Therapy: From a Prospective Randomized Study. Int J Radiat Oncol Biol Phys. 2023 Sep 1;117(1):74-86. doi: 10.1016/j.ijrobp.2023.02.061. Epub 2023 Apr 11.
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
147 participants (actual enrollment reported by the registry).
First Submitted
March 26, 2008
First Posted
October 14, 2009
Study Start
February 2009
Date type not reportedThis date has not been verified as actual or estimated.
Chemoradiotherapy With Gemcitabine/S-1 vs Gemcitabine/S-1 for Locally Advanced Pancreatic Cancer
Contact the study team to confirm eligibility.
Yu-Lin Lin, M.D.
National Taiwan University Hospital
Primary Completion
January 2016
Actual (reported)Study Completion
January 2016
Actual (reported)Last Updated
May 4, 2016
Record last verified: 2009-10
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