Preventive effect of Goshajinkigan on peripheral neurotoxicity of FOLFOX therapy: A placebo-controlled double blind randomized Phase II study (The GONE Study)
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https://www.omicsdi.org/dataset/ecrin-mdr-crc/2617692
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Interventions: FOLFOX4(L-OHP85mg/m2, l-LV100mg/m2x2, 5FU400mg/m2(bolus)x2, 5FU600mg/m2x2(civ)) or mFOLFOX6(L-OHP85mg/m2, l-LV200mg/m2, 5FU400mg/m2(bolus), 5FU240mg/m2(civ)).Cycles of chemotherapy are given every 2 weeks until PD or unacceptable toxicity occurred. Goshajinkigan(GJG) is given orally at a dose of 2.5 g three times a day for 26 weeks starting on the day of L-OHP infusion.
FOLFOX4(L-OHP85mg/m2, l-LV100mg/m2x2, 5FU400mg/m2(bolus)x2, 5FU600mg/m2x2(civ)) or mFOLFOX6(L-OHP85mg/m2, l-LV200mg/m2, 5FU400mg/m2(bolus), 5FU240mg/m2(civ)).Cycles of chemotherapy are given every 2 weeks until PD or unacceptable toxicity occurred. Placebo is given orally at a dose of 2.5 g three times a day for 26 weeks starting on the day of L-OHP infusion.
Primary outcome(s): The incidence of peripheral neurotoxicity ≥grade 2 after eight cycles of chemotherapy.
Study Design: Parallel Randomized
创建时间：
2009-05-15
