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Table 1 Phase III studies of adjuvant 5-fluorouracil based therapy#.

From: Primary resection versus neoadjuvant chemoradiation followed by resection for locally resectable or potentially resectable pancreatic carcinoma without distant metastasis. A multi-centre prospectively randomised phase II-study of the Interdisciplinary Working Group Gastrointestinal Tumours (AIO, ARO, and CAO)

Study year Number of patients Inclusion criteria Resection status 5-FU based therapy (months) Follow-up (months) p Preoperative diagnostics Postoperative Imaging Inked margin
GITSG-1985 [10] 49 R0 RCT 21.0 10.9 0.005 No No No
EORTC-1999 [11] 114* R0 RCT 17.1 12.6 0.099 No No No
ESPAC-1-2004 [12] 289§ R0 or R1 Cx 21.6 16.9 n.a. No No No
  1. # Median survival rates from three randomised studies in patients with resected pancreatic carcinoma. None of these trials used either high quality preoperative imaging to evaluate resectability, or postoperative imaging, to exclude tumour persistence or distant metastasis.
  2. * The EORTC trial comprised 218 patients with periampullary and pancreatic carcinoma. The results shown here are based upon the 114 patients with pancreatic carcinoma.
  3. § 541 patients were included into ESPAC-1, but only 289 were included into 2 × 2 factorial randomisation. Trial arms: observation, chemotherapy, chemoradiation, chemoradiation followed by chemotherapy. The table gives the survival rates fort he best treatment arm (chemotherapy) and observation.