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)
2 other identifiers
interventional
450
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 1999
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 1999
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 22, 2005
CompletedFirst Posted
Study publicly available on registry
August 23, 2005
CompletedJanuary 18, 2007
August 1, 2006
August 22, 2005
January 17, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression free survival
Secondary Outcomes (3)
Overall survival
Complete remission rate
Toxicity
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tokai University
Isehara, Kanagawa, 259-1193, Japan
Related Publications (1)
Ohmachi K, Tobinai K, Kobayashi Y, Itoh K, Nakata M, Shibata T, Morishima Y, Ogura M, Suzuki T, Ueda R, Aikawa K, Nakamura S, Fukuda H, Shimoyama M, Hotta T; members of the Lymphoma Study Group of the Japan Clinical Oncology Group (JCOG-LSG). Phase III trial of CHOP-21 versus CHOP-14 for aggressive non-Hodgkin's lymphoma: final results of the Japan Clinical Oncology Group Study, JCOG 9809. Ann Oncol. 2011 Jun;22(6):1382-1391. doi: 10.1093/annonc/mdq619. Epub 2010 Dec 31.
PMID: 21196441DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Tomomitsu Hotta, MD, PhD
Tokai University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 22, 2005
First Posted
August 23, 2005
Study Start
February 1, 1999
Study Completion
February 1, 2005
Last Updated
January 18, 2007
Record last verified: 2006-08