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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Non-Hodgkin's Lymphoma

Intervention / Treatment
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* Drug: Standard CHOP
* Drug: Bi-CHOP (dose intensified CHOP)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Standard CHOP|nan|
|Drug: Bi-CHOP (dose intensified CHOP)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  |  | 
| Complete remission rate |  |  | 
| Toxicity |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-Hodgkin's lymphoma, intermediate-grade lymphoma, high-grade lymphoma, CHOP protocol, granulocyte-colony stimulating factor