Spots Global Cancer Trial Database for R-CHOP Versus R-CDOP as First-line Treatment for Elderly Patients With Diffuse Large-B-cell Lymphoma
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Trial Identification
Brief Title: R-CHOP Versus R-CDOP as First-line Treatment for Elderly Patients With Diffuse Large-B-cell Lymphoma
Official Title: Rituximab, Cyclophosphamide, Vincristine, and Prednisone in Combination With Doxorubicin (R-CHOP) Versus in Combination With Pegylated-liposomal Doxorubicin (R-CDOP) as First-line Treatment for Elderly Patients With Diffuse Large-B-cell Lymphoma: a Randomised, Multicentre, Non-inferiority Study
Study ID: NCT02428751
Conditions
Study Description
Brief Summary: The combination of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP regimen) has been the first-line chemotherapy for elderly patients with diffuse large B-cell lymphoma (DLBCL). The treatment-related toxicities, especially the severe cardiac toxicities induced by anthracycline drugs (doxorubicin), have become a major concern among elderly patients. Pegylated liposomal doxorubicin is a formulation of doxorubicin with a prolonged circulation time and unique toxicity profile. Previous single arm studies of elderly patients with lymphoma used pegylated liposomal doxorubicin instead of traditional doxorubicin in combination with rituximab, cyclophosphamide, vincristine, and prednisone (the novel R-CDOP regimen), and demonstrated better safety profile, including less bone marrow suppression and less cardiac toxicities, while maintaining the efficacy. However, the efficacy and safety of these two regimens (R-CHOP and R-CDOP) have not been head-to-head compared in a randomized study. The aim of this study is to compare the efficacy and safety of R-CDOP (rituximab, cyclophosphamide, pegylated liposomal doxorubicin, vincristine, and prednisone) and R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) in previously untreated elderly patients with DLBCL.
Detailed Description:
Eligibility
Minimum Age: 60 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Guangdong Provincial People's Hospital, Guangzhou, Guangdong, China
Nanfang Hospital of Southern Medical Unversity, Guangzhou, Guangdong, China
Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China
The Second Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China
The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China
Wujing Zongdui Hospital of Guangdong Province, Guangzhou, Guangdong, China
Contact Details
Name: Wen-qi Jiang, M.D.
Affiliation: Sun Yat-sen University
Role: PRINCIPAL_INVESTIGATOR
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