Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Poster Discussion session -Gastrointestinal, non-colorectal

2025 - Randomized, Phase III Trial Comparing Adjuvant Gemcitabine (Gem) versus Gem plus Chemoradiation (CCRT) in Curatively Resected Pancreatic Ductal Adenocarcinoma (PDAC) – A Taiwan Cooperative Oncology Group Study


19 Oct 2018


Poster Discussion session -Gastrointestinal, non-colorectal


Cytotoxic Therapy;  Radiation Oncology

Tumour Site

Pancreatic Adenocarcinoma


Hui-Ju Chang


Annals of Oncology (2018) 29 (suppl_8): viii205-viii270. 10.1093/annonc/mdy282


H. Chang1, Y. Chiu1, J. Chen2, C. Li3, C. Ho4, Y. Shyr5, W. Chiou6, C. Yeh7, R. Hsieh8, Y. Lin9, Y. Tien10, T. Hwang7, Y. Shan11, L. Chen12

Author affiliations

  • 1 National Institute Of Cancer Research, National Health Research Institutes, 35053 - Miaoli/TW
  • 2 Hematology And Oncology, Chang Gung Memorial Hospital, 333 - Taoyuan/TW
  • 3 Medical Oncology, Taipei Veterans General Hospital, Taipei City/TW
  • 4 Internal Medicine, Tri-service general hospital, Taipei/TW
  • 5 Surgery, Taipei Veterans General Hospital, Taipei City/TW
  • 6 Internal Medicine, Chung Gung University, 333 - Tao Yuan/TW
  • 7 Surgery, Chung Gung University, 333 - Tao Yuan/TW
  • 8 Internal Medicine, Mackay Memorial Hospital, Taipei/TW
  • 9 Oncology, National Taiwan University Hospital, Taipei/TW
  • 10 Surgery, National Taiwan University Hospital, Taipei/TW
  • 11 Medical Oncology, National Cheng Kung University, 701 - Tainan/TW
  • 12 National Institute Of Cancer Research, National Health Research Institutes, Tainan/TW


Login to access the resources on OncologyPRO.

If you do not have an ESMO account, please create one for free.

Abstract 2025


Adjuvant chemotherapy is the standard of care for PDAC after curative intent surgery. Current study aims to evaluate the role of additional consolidation CCRT to 6-month adjuvant Gem therapy in resectable PDAC.


Patients with R0/R1 resected PDAC, and negative CT finding within 2 weeks and CA-19.9 <2.5x NUL within one week before registration were eligible. Enrolled patients were stratified by section margin, tumor size and lymph node status then randomized to have either 6 cycles of weekly gemcitabine, day 1, 8 and 15 every 28 days (Arm 1) or 3 cycles of weekly Gem followed by Gem-based CCRT and then another 3 cycles of Gem (Arm 2). The treatment should be initiated within 8 weeks after surgery. The primary end-point was recurrence-free survival (RFS). Secondary end points were overall survival (OS), progression pattern, safety profile and quality of life.


Between 2009 and 2015, 147 patients were included, 74 in Arm 1 and 73 in Arm 2. With a minimum of 2 years follow-up, the median RFS was similar between Arm 1 and Arm 2: 12.1(95% CI, 9·0-15·8) versus 13.3 (95% CI, 10.0-17.1) months, (hazard ratio 0.96 [95% CI, 0·67-1·37, p = 0.80]); while OS was 23·5 (95% CI, 18·1-30.8) versus 21·5 (95% CI, 16·7-28·1) months, (hazard ratio 1.07 [95% CI, 0·74-1·55, p = 0·73]). Local recurrence rate was marginally less in Arm 2 (17.6% vs 15.1%, p = 0·68). Grade 3/4 toxicity was 66% vs 73% in Arm 1 and 2, respectively, p = 0·34. Patients in Arm 1 had a trend of better global health status, p = 0·12.


This is the first randomized trial using survival as primary endpoint to evaluate the role of add-on CCRT for curatively resected PDAC receiving standard, adjuvant Gem therapy. Despite a trend of better loco-regional control, the add-on CCRT did not improve the RFS and OS in such a patient population. Systemic chemotherapy should remain as the standard of care for PDAC after curative-intent surgery.

Clinical trial identification


Legal entity responsible for the study

Taiwan Cooperative Oncology Group.


National Health Research Institutes.

Editorial Acknowledgement


J-S. Chen: Research funding: Ono Pharmaceutical, MSD Oncology, MedImmune, Lilly, TTY Biopharm, Daiichi Sankyo, Orient EuroPharma. L-T. Chen: Research funding: Novartis, Merck, Serono, TTY, Polaris, SyncorePharm, Pfizer, BMS; Honoraria: Ono, Eli Lilly, MSD, PharmaEngine, TTY, SyncorePharm, Novartis, Astra Zeneca, Ipsen; Patents & Royalties of ENO-1mAb/HuniLife; Membership on board of directors or advisory committes: PharmaEngine. All other authors have declared no conflicts of interest.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.