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Hysterectomy after Chemoradiotherapy for Stage Ib2 and IIb Cervical Cancer Vivek Nama UHBT
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Existing Evidence: Keys trial Cervical Cancers > 4cm RCT post radiotherapy 30cGy to point A the hysterectomy arm 40cGy to Point A in the non hysterectomy arm 256 (123 in each arm)
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Results Hysterectomy did not increase the grade 3 and 4 adverse effects 46% progressed among the radiation group and 37% progressed in the adjuvant hysterectomy group 5 years local relapse was 27% in radiation only group and 14% in combined treatment group Overall survival not different - distant relapses
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Changes Chemoradiotherapy Significant decrease in local and distant recurrence (CD008285) MRI Combined histology Negative histology Negative histology had higher distant recurrence
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Post Chemo-radiotherapy MRI showing complete response Intervention Arm – Simple Hysterectomy Control Arm – Routine follow up Routine follow up 3 months after completion of treatment for 2 years Routine follow up 6 monthly for 3 years
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Outcomes: Primary outcome: Overall Survival Secondary Outcome measures: Progression free survival, Treatment related morbidity (CTACE 4.0) Quality of life (EORTC/FACT)
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Has any one tried? French Difficulty recruiting Surgeons felt that randomization into a non intervention arm was harmful to their patients
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Funding? NIHR agenda Charity organizations NIHR CRN funds
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Why us? Centre Bristol Bath Taunton Exeter Cheltenham Truro 10 cases each
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Thank you
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