Comparison Study of Doxorubicin Versus Epirubicin-induced Cardiotoxicity in Patients With DLBCL

NCT ID: NCT00854568

Last Updated: 2014-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 398 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2013-02-28

Brief Summary

The aim of this study is to compare CHOP versus CEOP-induced cardiotoxicity in patients with aggressive B-cell lymphoma. The hypothesis is epirubicin is associated with less cardiotoxicity without compromising the efficacy.

Detailed Description

The doxorucin-containing regimen (CHOP) and epirubicin-containing regimen (CEOP) are both frequently used in patients with aggress B-cell lymphoma in out institution. According to a Cochrane meta-analysis, epirubicin is less cardiotoxic than doxorubicin on a mg per mg basis. However, compared with 50mg/m2 of doxorubicin in CHOP, epirubicin was usually used at a higher dose (70mg/m2) to treat non-Hodgkin's lymphoma (NHL). Because of the correlation between cumulative dose and risk of cardiotoxicity, it is reasonable to speculate that CEOP (70mg/m2) has less cardiotoxicity than CHOP (50mg/m2) when both regimens are administered with similar cycles.

Conditions

Lymphoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CEOP regimen

CEOP regimen

Group Type: EXPERIMENTAL

CEOP regimen

Intervention Type: DRUG

cyclophosphamide 750mg/m2 IV day 1 epirubicin 70mg/m2 IV day 1 vincristine 1.4mg/m2 IV day1 (maximum: 2mg) prednisone 50mg PO days 1\~5 twice per day Or combined with rituximab 375mg/m2 IV day 0

CHOP regimen

CHOP regimen

Group Type: ACTIVE_COMPARATOR

CHOP regimen

Intervention Type: DRUG

cyclophosphamide 750mg/m2 IV day 1 doxorubicin 50mg/m2 IV day 1 vincristine 1.4mg/m2 IV day1 (maximum: 2mg) prednisone 50mg PO days 1\~5 twice per day Or combined with rituximab 375mg/m2 IV day 0

Interventions

CEOP regimen

cyclophosphamide 750mg/m2 IV day 1 epirubicin 70mg/m2 IV day 1 vincristine 1.4mg/m2 IV day1 (maximum: 2mg) prednisone 50mg PO days 1\~5 twice per day Or combined with rituximab 375mg/m2 IV day 0

Intervention Type: DRUG

CHOP regimen

cyclophosphamide 750mg/m2 IV day 1 doxorubicin 50mg/m2 IV day 1 vincristine 1.4mg/m2 IV day1 (maximum: 2mg) prednisone 50mg PO days 1\~5 twice per day Or combined with rituximab 375mg/m2 IV day 0

Intervention Type: DRUG

Other Intervention Names

CEOP; CHOP

Eligibility Criteria

Inclusion Criteria

• Previously untreated aggressive B-cell lymphoma
• Age range 18-75 years old
• ECOG performance status 0-2
• Life expectancy of more than 3 months
• Adequate organ function

Exclusion Criteria

• Previous serious cardiac disease
• History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
• Pregnant or lactating women
• Serious uncontrolled diseases and intercurrent infection

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Ye Guo

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ye Guo, MD

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

LMTG 09-01

Identifier Type: -

Identifier Source: org_study_id