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Effect of dose-escalation protocol for capecitabine on dose in 4th cycle of chemotherapy

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NIAID Data Ecosystem2026-03-12 收录
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https://www.omicsdi.org/dataset/ecrin-mdr-crc/56395
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Intervention is procedure for initial dosing for capecitabine: dose-escalation protocol (procedure for dosing for capecitabine) Use same agents as control arm including capecitabine and other chemotherapy as standard regimen for each type of cancer. No difference for duration of treatment between Arm1 and Arm2. Starting capecitabine with 75% of target dose in 1st cycle and escalate 500 mg/d for each cycle if there was grade 1 or no adverse event until achievement of target dose or presence of grade 2 adverse event. Grade 2 adverse event that is managed by supportive care and resolved to grade 0-1 will preclude dose escalation. adjust dose if toxicities occured as protocol (standard of care). other chemotherapy and supportive care were managed as standard of care,Starting capecitabine with 100% of target dose at 1st cycle of treatment and adjust if toxicities occured as protocol (standard of care). other chemotherapy and supportive care were managed as standard of care.;Experimental Drug,Active Comparator Drug;dose-escalation arm,standard dose arm Primary outcome(s): dose of capecitabine at 4th cycle at initial of 4th cycle of treatment Record the dose prescribed by physician (divided dose by patient's body surface area; record for 4 digits without decimal) for assessment of noninferiority of mean difference between two group Study Design: Randomized
创建时间:
2021-07-15
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