- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00133302
Study of Standard CHOP Versus Biweekly CHOP in Aggressive Non-Hodgkin's Lymphoma (JCOG9809)
January 17, 2007 updated by: Japan Clinical Oncology Group
Randomized Phase III Study of Standard CHOP (S-CHOP) Versus Biweekly CHOP (Bi-CHOP) in Aggressive Non-Hodgkin's Lymphoma (JCOG9809)
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).
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment
450
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kanagawa
-
Isehara, Kanagawa, Japan, 259-1193
- Tokai University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 69 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Progression free survival
|
Secondary Outcome Measures
Outcome Measure |
---|
Toxicity
|
Overall survival
|
Complete remission rate
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Tomomitsu Hotta, MD, PhD, Tokai University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 1999
Study Completion
February 1, 2005
Study Registration Dates
First Submitted
August 22, 2005
First Submitted That Met QC Criteria
August 22, 2005
First Posted (Estimate)
August 23, 2005
Study Record Updates
Last Update Posted (Estimate)
January 18, 2007
Last Update Submitted That Met QC Criteria
January 17, 2007
Last Verified
August 1, 2006
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- JCOG9809
- C000000036
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Non-Hodgkin's Lymphoma
-
Memorial Sloan Kettering Cancer CenterRecruitingNon-Hodgkin Lymphoma | Non-Hodgkin's Lymphoma, Relapsed | Non-Hodgkin's Lymphoma RefractoryUnited States
-
Immune DesignMerck Sharp & Dohme LLCTerminatedFollicular Low Grade Non-Hodgkin's Lymphoma
-
PrECOG, LLC.Genentech, Inc.CompletedFollicular Lymphoma | Non-Hodgkin's Lymphoma Follicular | Non-Hodgkin's Lymphoma, Adult High GradeUnited States
-
Haihe Biopharma Co., Ltd.RecruitingAdvanced Solid Tumor | Non-Hodgkin's Lymphoma, Relapsed | Non-Hodgkin's Lymphoma RefractoryUnited States, China
-
University Health Network, TorontoCompletedHodgkin's Lymphoma | Non Hodgkin's LymphomaCanada
-
Tarapeutics Science Inc.RecruitingAdvanced Solid Tumor | Non-Hodgkin's Lymphoma, Relapsed | Non-Hodgkin's Lymphoma RefractoryChina
-
Estrella Biopharma, Inc.Eureka Therapeutics Inc.Not yet recruitingLymphoma | Lymphoma, Non-Hodgkin | Non-Hodgkin's Lymphoma | Non-Hodgkin Lymphoma | Refractory B-Cell Non-Hodgkin Lymphoma | Refractory Non-Hodgkin Lymphoma | High-grade B-cell Lymphoma | CNS Lymphoma | Lymphomas Non-Hodgkin's B-Cell | Relapsed Non-Hodgkin Lymphoma | Lymphoma, Non-Hodgkins | Large B-Cell Lymphoma and other conditions
-
Hoffmann-La RocheCompletedDiffuse Large B-Cell Lymphoma, Non-Hodgkin's LymphomaHong Kong, Germany, Philippines, Taiwan, Turkey, Canada, Australia, Austria, New Zealand, Thailand, Hungary, Italy, Korea, Republic of, Romania, Netherlands, Brazil, Indonesia, Croatia, Egypt, Portugal, Sweden, Colombia, Argentina, De... and more
-
SCRI Development Innovations, LLCBiogenCompleted
-
Auxilio Mutuo Cancer CenterCompletedRefractory Aggressive Non-Hodgkin's Lymphoma | Relapsing Aggressive Non-Hodgkin's Lymphoma
Clinical Trials on Standard CHOP
-
Ruijin HospitalThe First Affiliated Hospital of Anhui Medical University; The First Affiliated... and other collaboratorsRecruiting
-
Haruhiko FukudaMinistry of Health, Labour and Welfare, JapanCompleted
-
Emergent BioSolutionsTerminated
-
Yune ZhaoUnknownHard Nuclear Cataract | Corneal Endothelial Cell | Progressive Cracking TechniqueChina
-
Sherief Abd-ElsalamRecruiting
-
Ruijin HospitalActive, not recruitingPeripheral T-cell LymphomaChina
-
Sun Yat-sen UniversityCompletedDiffuse Large B-cell Lymphoma
-
Jiangsu HengRui Medicine Co., Ltd.Not yet recruitingPeripheral T-cell Lymphoma
-
Nanjing Yoko Biomedical Co., Ltd.RecruitingDiffuse Large B-Cell Lymphoma, Unspecified SiteChina
-
Children's Hospital of PhiladelphiaNational Institute of Mental Health (NIMH); University of PennsylvaniaEnrolling by invitation