85936
document
A randomized trial of radiation therapy compared to split course radiation therapy combined with mitomycin C and 5 fluorouracil as initial treatment for advanced laryngeal and hypopharyngeal squamous carcinoma . Two hundred and twelve patients with previously untreated advanced squamous carcinoma of the larynx or hypopharynx were randomized to receive initial treatment with radiotherapy , 50 Gy in 20 fractions in 28 days or split course radiotherapy and concurrent chemotherapy , 25 Gy in 10 fractions in 14 days followed by a 4 week rest and a further 25 Gy in 10 fractions in 14 days starting on day 43 ; Mitomycin C was given on day 1 and day 43 and 5FU continuous infusions on days 1 -- 4 and days 43 -- 46 . Surgery was reserved for persistent or recurrent disease . Two hundred and nine of the 212 patients randomized were included in the analyses . Outcome analyses were performed at a median follow-up interval of 4.4 years . No patients were lost to follow-up . No significant difference was found between the two arms for the end points of local relapse-free rate ( p = 0.91 ) , regional relapse-free rate ( p = 0.17 , adjusted ) or overall survival ( p = 0.86 ) . Eight-eight patients had attempted surgical resection following radiotherapy failure . The contribution of salvage surgery to overall survival was similar for both arms of the study as was the surgical complication rate . Serious late radiation toxicity was minimal ( 3 % in the RT group , 0 % in the radiation therapy plus chemotherapy group ) . The result of the trial shows no advantage in terms of local control or survival for the experimental treatment arm of split course radiotherapy and concurrent chemotherapy with Mitomycin C and 5 Fluorouracil compared to radiotherapy alone .
85937
Intervention_Physical
radiation therapy
85938
Intervention_Physical
split course radiation therapy
85939
Intervention_Pharmacological
mitomycin C
85940
Intervention_Pharmacological
5 fluorouracil
85941
Intervention_Physical
radiotherapy
85942
Intervention_Physical
split course radiotherapy
85943
Intervention_Pharmacological
concurrent chemotherapy
85944
Intervention_Pharmacological
Mitomycin C
85945
Intervention_Pharmacological
5FU
85946
Intervention_Physical
radiotherapy
85947
Intervention_Physical
radiotherapy
85948
Intervention_Pharmacological
concurrent chemotherapy
85949
Intervention_Pharmacological
Mitomycin C
85950
Intervention_Pharmacological
5 Fluorouracil
85951
Outcome_Physical
local relapse-free rate
85952
Outcome_Physical
regional relapse-free rate
85953
Outcome_Mortality
overall survival
85954
Outcome_Physical
surgical resection following radiotherapy failure
85955
Outcome_Mortality
overall survival
85956
Outcome_Adverse-effects
surgical complication rate
85957
Outcome_Physical
Serious
85958
Outcome_Adverse-effects
late radiation toxicity
85959
Participant_Condition
advanced laryngeal and hypopharyngeal squamous carcinoma .
85960
Participant_Sample-size
Two hundred and twelve
85961
Participant_Condition
previously untreated advanced squamous carcinoma of the larynx or hypopharynx