Status:
TERMINATED
Study of Standard CHOP Versus Biweekly CHOP in Aggressive Non-Hodgkin's Lymphoma (JCOG9809)
Lead Sponsor:
Japan Clinical Oncology Group
Collaborating Sponsors:
Ministry of Health, Labour and Welfare, Japan
Conditions:
Non-Hodgkin's Lymphoma
Eligibility:
All Genders
15-69 years
Phase:
PHASE3
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 ...
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 endp...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 1999
Trial Type :
INTERVENTIONAL
End Date :
February 1 2005
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT00133302
Start Date
February 1 1999
End Date
February 1 2005
Last Update
January 18 2007
Active Locations (1)
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1
Tokai University
Isehara, Kanagawa, Japan, 259-1193