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document
A randomised trial of radiotherapy compared with cisplatin chemo-radiotherapy in patients with unresectable squamous cell cancer of the esophagus . BACKGROUND AND PURPOSE Following our phase II experience , a randomised trial was undertaken to evaluate the efficacy of adding chemotherapy to radiotherapy in patients with unresectable squamous cell cancer of the esophagus . PATIENTS AND METHODS Patients randomised to the RT group received 50 Gy/25 fx/5 weeks of teletherapy followed 1-2 weeks later with 12 Gy/2 fx of high-dose-rate intra-lumenal brachytherapy spaced a week apart . Following the first 3 years of recruitment , due to unexpected late morbidity , brachytherapy was excluded and the protocol modified to 66 Gy/33 fx/6.5 weeks . The CRT group received identical radiotherapy with concurrent weekly cisplatin at 35 mg/m ( 2 ) for 6-7 cycles . RESULTS Between April 1999 and December 2005 , 125 patients were randomised to a RT ( n=60 ) or CRT group ( n=65 ) . Radiotherapy treatment was completed in 78 % ( 47/60 ) of the RT group and 89 % ( 58/65 ) of the CRT group ( P=0.10 ) . Six or more cycles of cisplatin could be delivered in 63 % ( 41/65 ) , which resulted in RTOG grade 3 neutropenia of 3 % . Late morbidity in the form of ulcers ( 5 % vs. 15 % odds ratio 0.29 , 95 % CI 0.08-1.11 , P=0.08 ) and strictures ( 13 % vs. 28 % , odds ratio 0.40 , 95 % CI 0.16-1.01 , P=0.05 ) was observed in the RT and CRT groups , respectively . At a median follow up of 23 months of all patients alive ( range 6-82 months ) and with 95/125 events , the median , 1 , 2 and 5 year projected survival was 7.1 months , 32.3 % , 22.8 % and 13.7 % vs. 13.4 months , 57.6 % , 38.9 % and 24.8 % for the RT and CRT groups , respectively ( hazard ratio 0.65 , 95 % CI 0.44-0.98 , P=0.038 ) . CONCLUSIONS The addition of concurrent cisplatin to radiotherapy resulted in a modest improvement in survival and was associated with manageable additional acute and late morbidity .
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Intervention_Physical
radiotherapy
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Intervention_Pharmacological
cisplatin chemo-radiotherapy
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Intervention_Pharmacological
adding chemotherapy to radiotherapy
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Intervention_Physical
RT group received 50 Gy/25 fx/5 weeks of teletherapy followed 1-2 weeks later with 12 Gy/2 fx of high-dose-rate intra-lumenal brachytherapy spaced a week apart .
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Intervention_Pharmacological
brachytherapy
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Intervention_Pharmacological
received identical radiotherapy with concurrent weekly cisplatin at 35 mg/m ( 2 ) for 6-7 cycles
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Intervention_Pharmacological
cisplatin
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Intervention_Pharmacological
radiotherapy
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Outcome_Other
efficacy
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Outcome_Other
RTOG grade 3 neutropenia
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Outcome_Physical
Late morbidity in the form of ulcers
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Outcome_Physical
strictures
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Outcome_Mortality
survival
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Outcome_Physical
modest improvement in survival
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Outcome_Physical
manageable additional acute
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Outcome_Mortality
late morbidity
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Participant_Condition
unresectable squamous cell cancer of the esophagus
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Participant_Condition
unresectable squamous cell cancer of the esophagus
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Participant_Sample-size
125