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Table 1 Phase III-studies for adjuvant therapy

From: The role of radiotherapy in multimodal treatment of pancreatic carcinoma

Group - Study Year Patients (n) Inclusion criteria Resection-Status Treatment arms Median overall survival (Months) p-value Preoperative imaging
GITSG-1985[18] 49 R0 CRT
Observation
21.0
10.9
0.005 No
EORTC-1999[22] 114* R0 CRT
Observation
17.1
12.6
0.099 No
ESPAC-1-2004[17] 289# R0 or R1 Cx
No Cx&
21.6
16.9
Not available No
CONKO-001-2007[19] 368 R0 or R1 Cx
Observation
22.1
20.2
0.06 Yes
RTOG 9704 2008[20] 442^ R0 or R1 CRT + GEM
CRT + 5-FU
20.6
16.9
0.033 Yes
  1. Abbreviations: 5-FU = 5-fluorouracil, CRT= chemoradiotherapy, Cx= chemotherapy, GEM= gemcitabine, n= number, R0 = clear resection, R1 = microscopically positive margins. Median overall survival rates from five randomized studies in patients with resected pancreatic carcinoma. None of these studies employed postoperative imaging to exclude tumour persistence or distant metastasis. *The EORTC study included 218 patients with periampullary and pancreatic carcinoma. The figures in the table are based upon the 114 patients with pancreatic carcinoma. #The ESPAC-1 study included 541 patients, but only 289 were included into the 2 × 2 factorial randomization. Arms: observation, chemotherapy, chemoradiotherapy, chemoradiotherapy followed by chemotherapy. The survival rates are given for the best treatment arm (chemotherapy) and observation. &The comparison arm comprises both, patients with observation and patients with chemoradiotherapy. ^The RTOG 9704-study included a total of 442 patients, 380 of them had pancreatic head tumours.