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document
Chemotherapy for operable gastric cancer : results of the Dutch randomised FAMTX trial . The Dutch Gastric Cancer Group ( DGCG ) . The aim of this trial was to investigate whether pre-operative chemotherapy leads to a 15 % higher curative resectability rate in patients with operable gastric cancer . In this randomised trial , patients were allocated to receive either four courses of chemotherapy using 5-fluorouracil , doxorubicin and methotrexate ( FAMTX ) prior to surgery or to undergo surgery only . Patients younger than 75 years of age with a good physical and mental condition and a histologically proven adenocarcinoma of the stomach without clinical or radiographic ( computed tomography scan ) evidence of distant metastases were eligible for this trial . Early gastric cancer or cardia carcinoma were excluded . The response to chemotherapy was evaluated after two and four courses . In case of progressive disease ( PD ) after two courses , patients were operated upon as soon as possible . Otherwise complete response ( CR ) partial response ( PR ) or stable disease ( SD ) , two more courses were scheduled . The standard surgical procedure was a limited lymphadenectomy ( D1 ) with staging biopsy of the para-aortic lymph nodes . Between September 1993 and February 1996 , 56 eligible and evaluable patients were entered : 27 were randomised to receive FAMTX before surgery and 29 to undergo surgery only . In the FAMTX + surgery treatment group , 15/27 ( 56 % ) had curative resections versus 18/29 ( 62 % ) in the surgery only arm . There was no difference in the frequency of TNM stages I + II in both treatment arms : 15/27 versus 15/29 . Due to PD and/or toxicity , 12 patients ( 44 % ) could not complete the planned four courses of FAMTX . Response evaluation after chemotherapy was possible in 25 patients : 2 CR , 6 PR , 8 SD and 9 PD . The difference in curative resectability rate was 6.5 % ( 95 % confidence interval -32 to +19 % ) in favour of surgery only . Downstaging for stages I + II did not occur . PD was more often the reason for not completing the planned four courses than toxicity . More active regimens than FAMTX are required for future randomised trials .
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Intervention_Pharmacological
Chemotherapy
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Intervention_Pharmacological
chemotherapy
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Intervention_Pharmacological
5-fluorouracil , doxorubicin and methotrexate ( FAMTX ) prior to surgery
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Intervention_Control
surgery only
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Intervention_Pharmacological
chemotherapy
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Intervention_Pharmacological
FAMTX
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Outcome_Other
curative resectability rate
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Outcome_Other
curative resections
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Outcome_Physical
frequency of TNM stages I + II
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Outcome_Adverse-effects
toxicity
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Outcome_Other
curative resectability
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Participant_Condition
operable gastric cancer :
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Participant_Condition
Dutch