300
Participants
Start Date
January 31, 2013
Primary Completion Date
December 31, 2026
Study Completion Date
December 31, 2027
Single agent of cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexate
Procedure: Routine chemotherapeutic regimens using one out of cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexate (CDEFM) as single agent was performed 30\~60 days before surgery:cyclophosphamide 100mg/M2, doxorubicin 60mg/M2, epirubicin 100mg/M2, fluorouracil 500mg/M2, or methotrexate 50mg/M2.The agent was given on a regular route of IV administration on the 1st and 8th day of each cycle, 28 days per cycle, totally 6 cycles. Subsequently, there was a 30-day interval between the last cycle and radical surgery.
cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexate (CDEFM)
Procedure: Routine chemotherapeutic regimens using two agents from cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexate (CDEFM) as combinatorial treatment was performed 30\~60 days before surgery:cyclophosphamide 100mg/M2, doxorubicin 60mg/M2, epirubicin 100mg/M2, fluorouracil 500mg/M2, or methotrexate 50mg/M2.The agents were given on a regular route of IV administration on the 1st and 8th day of each cycle, 28 days per cycle, totally 6 cycles. Subsequently, there was a 30-day interval between the last cycle and radical surgery.
Placebo
Procedure: Routine placebo standardized in clinical oncology was provided to patients to replace any chemotherapeutic agent.
RECRUITING
China-Japan Union Hospital, Jilin University, Changchun
RECRUITING
Shanghai 10th People's Hospital, Tongji University School of Medicine, Shanghai
RECRUITING
Ganzhou City People's Hospital, Ganzhou
Shanghai 10th People's Hospital
OTHER
China-Japan Union Hospital, Jilin University
OTHER
Ganzhou City People's Hospital
OTHER
Shanghai Jiao Tong University School of Medicine
OTHER