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Chemoradiotherapy with concurrent gemcitabine and cisplatin with or without sequential chemotherapy with gemcitabine/cisplatin vs chemoradiotherapy with concurrent 5-fluorouracil in patients with locally advanced pancreatic cancer -- a multi-centre randomised phase II study . BACKGROUND No standard treatment for locally advanced pancreatic cancer ( LAPC ) is defined . PATIENTS AND METHODS Within a multi-centre , randomised phase II trial , 95 patients with LAPC were assigned to three different chemoradiotherapy ( CRT ) regimens : patients received conventionally fractionated radiotherapy of 50 Gy and were randomised to concurrent 5-fluorouracil ( 350 mg m ( -2 ) per day on each day of radiotherapy , RT-5-FU arm ) , concurrent gemcitabine ( 300 mg m ( -2 ) ) , and cisplatin ( 30 mg m ( -2 ) ) on days 1 , 8 , 22 , and 29 ( RT-GC arm ) , or the same concurrent treatment followed by sequential full-dose gemcitabine ( 1000 mg m ( -2 ) ) and cisplatin ( 50 mg m ( -2 ) ) every 2 weeks ( RT-GC+GC arm ) . Primary end point was the overall survival ( OS ) rate after 9 months . RESULTS The 9-month OS rate was 58 % in the RT-5-FU arm , 52 % in the RT-GC arm , and 45 % in the RT-GC+GC arm . Corresponding median survival times were 9.6 , 9.3 , and 7.3 months ( P=0.61 ) respectively . The intent-to-treat response rate was 19 , 22 , and 13 % respectively . Median progression-free survival was estimated with 4.0 , 5.6 , and 6.0 months ( P=0.21 ) . Grade 3/4 haematological toxicities were more frequent in the two GC-containing arms , no grade 3/4 febrile neutropaenia was observed . CONCLUSION None of the three CRT regimens tested met the investigators ' definition for efficacy ; the median OS was similar to those previously reported with gemcitabine alone in LAPC .
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Intervention_Pharmacological
concurrent gemcitabine and cisplatin with or without sequential chemotherapy with gemcitabine/cisplatin
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Intervention_Pharmacological
chemoradiotherapy with concurrent 5-fluorouracil
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Intervention_Pharmacological
radiotherapy
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Intervention_Pharmacological
5-fluorouracil
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Intervention_Pharmacological
radiotherapy
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Intervention_Pharmacological
concurrent gemcitabine
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Intervention_Pharmacological
cisplatin
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Intervention_Pharmacological
same concurrent treatment followed by sequential full-dose gemcitabine
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Intervention_Pharmacological
cisplatin
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Outcome_Mortality
overall survival ( OS ) rate after 9 months .
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Outcome_Mortality
9-month OS rate
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Outcome_Mortality
median survival times
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Outcome_Physical
intent-to-treat response rate
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Outcome_Mortality
Median progression-free survival
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Outcome_Adverse-effects
Grade 3/4 haematological toxicities
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Outcome_Adverse-effects
grade 3/4 febrile neutropaenia
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Participant_Condition
locally advanced pancreatic cancer --
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Participant_Condition
locally advanced pancreatic cancer ( LAPC )
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Participant_Sample-size
95
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Participant_Condition
LAPC