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document
Concomitant radiochemotherapy vs radiotherapy alone in patients with head and neck cancer : a Hellenic Cooperative Oncology Group Phase III Study . The primary objective of the present randomized phase III trial was to compare the 3-yr survival rate of patients treated with standard fractionated radiotherapy ( RT ) alone or with the same RT concomitantly with cisplatin ( DDP ) or carboplatin ( Cb ) . From January 1995 until July 1999 , 124 patients with histologically proven locally advanced non-nasopharyngeal head and neck cancer ( HNC ) were randomized to receive either RT monotherapy ( 70 Gy , Group A ) or the same RT concomitantly with DDP ( 100 mg/m2 on d 2 , 22 , 42 , Group B ) or Cb ( 7 AUC on d 2 , 22 , 42 , Group C ) . There were no significant differences in complete response rates between patients treated with RT alone or combined chemoradiotherapy . However , median time to progression ( TTP ) and overall survival ( OS ) were significantly longer in patients treated with concomitant chemoradiotherapy . Thus , median TTP was 6.3 , 45.2 , and 17.7 mo in groups A , B , and C respectively ( p = 0.0002 ) . Similarly , median OS was 12.2 , 48.6 , and 24.5 mo , respectively ( p = 0.0003 ) . At 3 yr follow-up , 17.5 % of patients in group A were alive compared to 52 % in group B and 42 % in group C ( p < 0.001 ) . Patients treated with concomitant chemoradiotherapy experienced more frequently severe hematological toxicity . Also , severe nausea/vomiting was more pronounced in group B , as expected . The present study clearly demonstrated that concomitant chemoradiotherapy with platinum analogs significantly prolongs 3-yr survival and median OS in patients with locally advanced HNC compared to conventional RT alone .
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Intervention_Physical
Concomitant radiochemotherapy
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Intervention_Physical
radiotherapy alone
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Intervention_Physical
standard fractionated radiotherapy ( RT )
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Intervention_Pharmacological
cisplatin ( DDP )
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Intervention_Pharmacological
carboplatin ( Cb )
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Intervention_Physical
RT monotherapy
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Intervention_Physical
RT concomitantly with DDP
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Intervention_Pharmacological
Cb
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Intervention_Physical
chemoradiotherapy
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Intervention_Pharmacological
concomitant chemoradiotherapy
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Intervention_Physical
concomitant chemoradiotherapy
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Intervention_Physical
concomitant chemoradiotherapy with platinum analogs
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Outcome_Mortality
3-yr survival rate
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Outcome_Other
complete response rates
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Outcome_Physical
median time to progression ( TTP )
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Outcome_Mortality
overall survival ( OS )
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Outcome_Physical
median TTP
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Outcome_Mortality
median OS
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Outcome_Mortality
alive
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Outcome_Physical
severe hematological toxicity
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Outcome_Adverse-effects
severe nausea/vomiting
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Outcome_Mortality
3-yr survival
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Outcome_Mortality
median OS