Trial | NCT00133302  Report issue

Title

Study of Standard CHOP Versus Biweekly CHOP in Aggressive Non-Hodgkin's Lymphoma (JCOG9809)
Randomized Phase III Study of Standard CHOP (S-CHOP) Versus Biweekly CHOP (Bi-CHOP) in Aggressive Non-Hodgkin's Lymphoma (JCOG9809)

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    450
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).
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 Started
Feb 28
1999
Study Completion
Feb 28
2005
Last Update
Jan 18
2007
Estimate

Drug Standard CHOP

Drug Bi-CHOP (dose intensified CHOP)

Criteria 

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
No Results Posted