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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.