Spots Global Cancer Trial Database for Trial of R-GemOx Versus R-miniCHOP Regimen in First-line Treatment of Elderly Diffuse Large B Cell Lymphoma
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Trial Identification
Brief Title: Trial of R-GemOx Versus R-miniCHOP Regimen in First-line Treatment of Elderly Diffuse Large B Cell Lymphoma
Official Title: Phase III,Randomized Controlled Trial of R-GemOx Versus R-miniCHOP Regimen in First-line Treatment of Elderly Diffuse Large B Cell Lymphoma
Study ID: NCT02767674
Conditions
Study Description
Brief Summary: The purpose of this study is to investigate efficacy and safety of R-GemOx Versus R-miniCHOP as first-line treatment of elderly patients with Diffuse large B cell lymphoma
Detailed Description: Gemcitabine and Oxaliplatin(GemOx) shows effective activity in patients with relapsed diffuse large-cell lymphoma and other solid tumors. Our Previous study showed that two-weekly regimen of rituximab combined with GemOx regimen acheived comparable response rate to R-miniCHOP.The investigators therefore design this open-label,phase III and random trial to compared the safety and efficacy of R-Gemox versus R-miniCHOP as first-line treatment of elderly patients with diffuse large B cell lymphoma. Primary Outcome Measures: • 2-year overall survival rate Secondary Outcome Measures: * 2-year progression free survival rate * overall response rate * safety and toxicity Enrollment:258 Study Start Date: June 2016 Primary Completion Date: June 2019
Eligibility
Minimum Age: 70 Years
Eligible Ages: OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Tongji Medical College of HUST, Wuhan, Hubei, China
The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital), NanJing, Jiangsu, China
QiLu Hospital of Shandong University, Jinan, Shandong, China
Shandong Province Hospital, Jinan, Shandong, China
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai, China
Sudan University Shanghai Cancer Center, Shanghai, Shanghai, China
Contact Details
Name: Wei Xu, M.D., Ph.D.
Affiliation: The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)
Role: PRINCIPAL_INVESTIGATOR
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