Study of Standard CHOP Versus Biweekly CHOP in Aggressive Non-Hodgkin's Lymphoma (JCOG9809)

Phase 3

Terminated

• Conditions: Non-Hodgkin's Lymphoma

• Registration Number: NCT00133302
• Lead Sponsor: Japan Clinical Oncology Group

Brief Summary

The purpose of this trial is to investigate the clinical benefit of the dose intensified regimen, Bi-CHOP in comparison to standard CHOP for advanced intermediate or high grade non-Hodgkin's lymphoma (NHL).

Detailed Description

The purpose of JCOG9809 was to determine whether treatment results of aggressive NHL could be improved by shortening intervals of CHOP chemotherapy with the prophylactic use of G-CSF. The primary endpoint was Progression Free Survival (PFS), and the planned accrual was 450. Until December, 2002, 323 patients with advanced aggressive NHL were randomized to standard CHOP arm (CHOP x 8, every three weeks) and biweekly CHOP arm (CHOP x 8, every two weeks).

Study Timeline

• Study Start: 1999-02
• Study Completion: 2005-02
• Study First Submitted: 2005-08-22
• Study First Submitted QC: 2005-08-22
• Study First Posted: 2005-08-23
• Status Verified: 2006-08
• Last Update Submitted: 2007-01-17
• Last Update Posted: 2007-01-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

• Intermediate- or high-grade non-Hodgkin's lymphoma, excluding cutaneous t-cell lymphoma (CTCL), adult T-cell leukemia-lymphoma (ATL) and T-cell lymphoblastic lymphoma (T-LbL) (Working Formulation)
• Ann Arbor stage: II, III, IV
• No prior chemotherapy or radiotherapy
• Age: 15 to 69
• Performance status (PS): 0, 1, 2
• WBC >= 3,000 /mm3, ANC >= 1,200 /mm3, Platelet >= 75,000 /mm3
• GOT/GPT <= 5 x Normal Upper Limit, T-Bil <= 2.0 mg/dL
• Creatinine <= 2.0 mg/dL
• Normal ECG, Ejection Fraction >= 50%
• PaO2 >= 65 mmHg
• Written informed consent

Exclusion Criteria

• Uncontrollable diabetes mellitus
• Severe complication (infection, heart failure, renal failure, liver failure, etc)
• Anamnesis of heart disease
• Acute or chronic hepatitis, liver cirrhosis and portal hypertension
• Synchronous or metachronous malignancy
• Severe pulmonary dysfunction
• Central nervous system (CNS) invasion
• HIV positive
• Hepatitis B surface antigen (HBs-Ag) positive
• Hepatitis C virus antibody (HCV-Ab) positive

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Progression free survival

Secondary Outcome Measures

Name	Time	Method
Overall survival
Complete remission rate
Toxicity

Trial Locations

Locations (1)

Tokai University; 🇯🇵 Isehara, Kanagawa, Japan