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document
A prospective randomized study concerning the point A dose in high-dose rate intracavitary therapy for carcinoma of the uterine cervix . The final results . PURPOSE High-dose rate ( HDR ) remote afterloading intracavitary therapy has been recognized as an effective and safe treatment modality for carcinoma of the uterine cervix . Since 1983 , a prospective randomized study was started in order to investigate the more advantageous treatment schedule with keeping the local control rate . This paper reports the final results in terms of survival , local control and complications . PATIENTS AND METHODS Between January 1983 and February 1989 , a total of 165 patients with carcinoma of the uterine cervix was entered in a prospective randomized study concerning the point A dose of HDR therapy ( 6 Gy/fraction vs 7.5 Gy/fraction ) and external irradiation dose at Department of Radiation Therapy , The Center for Adult Diseases , Osaka . UICC [ 20 ] stage distribution of patients was as follows : stage IA = 4 , stage IB = 33 , stage IIA = 18 , stage IIB = 38 , stage III = 57 , stage IV = 15 . RESULTS Overall 5-year cause specific survivals were as follows : stage IA = 100 % , stage IB = 96 % , stage IIA = 92 % , stage IIB = 79 % , stage III = 57 % , stage IV = 27 % . In each stage , 5-year survival rates in groups A and B were 100 % , 93 % in stage I , 82 % and 85 % in stage II , 62 % and 52 % in stage II and 22 % and 31 % in stage IV , respectively . There were no statistically significant differences among these survival curves in each stage . Five-year local failure rates were 16 % in group A and 16 % in group B ( p = 0.9096 ) , and corresponding distant failure rates were 23 % in group A and 19 % in group B ( p = 0.2955 ) . Moderate-to-severe complications requiring treatment ( Kottmeier 's grade 2 or more ) were noted in 6 patients ( 7 % ) in group A and 6 patients ( 7 % ) in group B . All of the bladder and rectal complications needed medical treatment ( Kottmeier 's grade 2 ) . Severe complications receiving surgery were noted in 4 patients ( A : 1 ; B : 3 ) , i.e. , small intestine 3 and sigmoid colon 1 patient . Another 1 patient ( A ) was dead of ileus . CONCLUSIONS There were no statistically significant differences between 2 treatment schedules in survival rates , failure patterns and complications rates . This fact suggests that small number of fractions ( 7.5 Gy/fraction ) may be advantageous because of short duration and a low load of treatment .
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Intervention_Pharmacological
high-dose rate intracavitary therapy
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Intervention_Pharmacological
High-dose rate ( HDR ) remote afterloading intracavitary therapy
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Intervention_Pharmacological
HDR therapy
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Intervention_Pharmacological
external irradiation dose at Department of Radiation Therapy
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Outcome_Mortality
5-year cause specific survivals
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Outcome_Mortality
5-year survival rates
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Outcome_Physical
Five-year local failure rates
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Outcome_Physical
Moderate-to-severe complications
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Outcome_Physical
bladder and rectal complications
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Outcome_Physical
Severe complications
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Outcome_Mortality
dead
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Outcome_Mortality
statistically significant differences between 2 treatment schedules in survival rates
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Outcome_Other
failure patterns
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Outcome_Physical
complications rates
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Participant_Condition
carcinoma of the uterine cervix
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Participant_Condition
carcinoma of the uterine cervix
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Participant_Sample-size
165
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Participant_Condition
carcinoma of the uterine cervix
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Participant_Sample-size
4
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Participant_Sample-size
33
83453
Participant_Sample-size
18
83454
Participant_Sample-size
38
83455
Participant_Sample-size
57
83456
Participant_Sample-size
15