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A randomized multicenter trial comparing resection and radiochemotherapy for resectable locally invasive pancreatic cancer . BACKGROUND Though the outcome of resection for locally invasive pancreatic cancer is still poor , it has gradually improved in Japan , and the 5-year survival is now about 10 % . However , the advantage of resection over radiochemotherapy has not yet been confirmed by a randomized trial . We conducted this study to compare surgical resection alone versus radiochemotherapy without resection for locally invasive pancreatic cancer using a multicenter randomized design . METHODS Patients with pancreatic cancer who met our preoperative criteria for inclusion ( pancreatic cancer invading the pancreatic capsule without involvement of the superior mesenteric artery or the common hepatic artery , or without distant metastasis ) underwent laparotomy . Patients with operative findings consistent with our criteria were randomized into a radical resection group and a radiochemotherapy group ( 200 mg/m ( 2 ) /day of intravenous 5-fluorouracil and 5040 cGy of radiotherapy ) without resection . The 2 groups were compared for mean survival , hazard ratio , 1-year survival , quality of life scores , and hematologic and blood chemical data . RESULTS Twenty patients were assigned to the resection group and 22 to the radiochemotherapy group . There was 1 operative death . The surgical resection group had better results than the radiochemotherapy group as measured by 1-year survival ( 62 % vs 32 % , P=.05 ) , mean survival time ( > 17 vs 11 months , P < .03 ) , and hazard ratio ( 0.46 , P=.04 ) . There were no differences in the quality of life score or laboratory data apart from increased diarrhea after surgical resection . CONCLUSIONS Locally invasive pancreatic cancer without distant metastases and major arterial invasion appears to be best treated by surgical resection .
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Intervention_Physical
resection and radiochemotherapy
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Intervention_Surgical
resection
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Intervention_Physical
radiochemotherapy
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Intervention_Surgical
surgical resection
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Intervention_Physical
radiochemotherapy
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Intervention_Physical
radical resection group
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Intervention_Physical
radiochemotherapy group
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Intervention_Physical
intravenous 5-fluorouracil and 5040 cGy of radiotherapy )
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Intervention_Physical
radiochemotherapy
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Outcome_Mortality
5-year survival
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Outcome_Mortality
mean survival
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Outcome_Physical
,
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Outcome_Adverse-effects
hazard ratio
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Outcome_Physical
,
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Outcome_Mortality
1-year survival
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Outcome_Other
quality of life scores
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Outcome_Physical
, and hematologic and blood chemical data
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Outcome_Mortality
operative death .
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Outcome_Physical
1-year survival
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Outcome_Physical
mean survival time
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Outcome_Physical
hazard ratio
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Outcome_Physical
quality of life score
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Outcome_Physical
laboratory data
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Outcome_Adverse-effects
diarrhea
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Participant_Condition
resectable locally invasive pancreatic cancer .
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Participant_Condition
Japan
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Participant_Sample-size
Twenty