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. 2022 Mar 24;16:1367. doi: 10.3332/ecancer.2022.1367

Table 4. Randomised large-scale trials for adjuvant therapy of resected PDAC in the modern era.

Trial Types of trial N Interventions Primary endpoint mDFS (months) mOS (months) Result
CONKO-001 [98] Phase III 368 G. vs. Observation DFS 13.4 vs. 6.7 22.8 vs. 20.2 Achieved primary endpoint
RTOG 9704 [99] RCT, Phase III 451(Pancreatic-388) 5-FU/Lv, → concurrent 5-FU-RT, --> 5-FU/Lv; vs. G.--> concurrent 5-FU-RT, followed by G. OS NR 20.5 vs. 17.1 Trend towards benefit with G, but statistically did not achieve endpoint
ESPAC-3 [101] RCT. Phase III 1088 G. vs. 5 -FU OS 14.3 vs. 14.1 23.6 vs. 23 Did not achieve primary endpoint
JASPAC-01 [100] RCT, Phase III (Non inferiority) 385 G. vs. S1 OS 11.3 vs. 22.9 (RFS) 25.5 vs. 46.5 Achieved primary endpoint
ESPAC-4 [103] RCT, Phase III 732 G-C. vs. G OS 13.9 vs. 13.1 28 vs. 25.5 Achieved primary endpoint
Canadian Cancer Trials Group and the Unicancer-GI–PRODIGE Group [102] RCT, Phase III 493 mFOLFIRINOX vs. G. DFS 21.6 vs. 12.8 54.4 vs. 35 Achieved primary endpoint
APACT [104] RCT, Phase III 866 nab-P/G vs. G. DFS 19.4 vs. 18.8 40.5 vs. 36. Did not achieve primary endpoint

N, Total number of patients; mDFS, Median Disease-free survival, mOS, Median Overall survival, JASPAC, Japan Adjuvant Study Group of Pancreatic Cancer; RTOG, Radiation Therapy Oncology Group, APACT, Adjuvant Therapy for Patients With Resected Pancreatic Cancer; G, Gemcitabine, 5-FU/LV - 5-fluorouracil/leucovorin, RT, Radiotherapy, RFS, Recurrence free survival, G-C, Gemcitabine-capecitabine, mFOLFIRINOX, Modified 5-fluorouracil-leucovorin-irinotecan-oxaliplatin, nab-P/G, Nab-Paclitaxel/gemcitabine, NR, Not reported.