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

Sponsors and Collaborators:	Japan Clinical Oncology Group Japanese Ministry of Health, Labor and Welfare
Information provided by:	Japan Clinical Oncology Group
ClinicalTrials.gov Identifier:	NCT00133302

Purpose

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). 　

Condition	Intervention	Phase
Non-Hodgkin's Lymphoma	Drug: Standard CHOP Drug: Bi-CHOP (dose intensified CHOP)	Phase III

MedlinePlus related topics: Lymphoma

Drug Information available for: Sargramostim Granulocyte-macrophage colony-stimulating factor Granulocyte colony-stimulating factor

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Randomized Phase III Study of Standard CHOP (S-CHOP) Versus Biweekly CHOP (Bi-CHOP) in Aggressive Non-Hodgkin's Lymphoma (JCOG9809)

Further study details as provided by Japan Clinical Oncology Group:

Primary Outcome Measures:

Progression free survival

Secondary Outcome Measures:

Overall survival
Complete remission rate
Toxicity

Estimated Enrollment:	450
Study Start Date:	February 1999
Estimated Study Completion Date:	February 2005

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).

Eligibility

Ages Eligible for Study:	15 Years to 69 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00133302

Locations

Japan, Kanagawa
Tokai University
Isehara, Kanagawa, Japan, 259-1193

Sponsors and Collaborators

Japan Clinical Oncology Group

Japanese Ministry of Health, Labor and Welfare

Investigators

Study Chair:

Tomomitsu Hotta, MD, PhD

Tokai University

More Information

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	JCOG9809, C000000036
Study First Received:	August 22, 2005
Last Updated:	January 17, 2007
ClinicalTrials.gov Identifier:	NCT00133302
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Japan Clinical Oncology Group:

Non-Hodgkin's lymphoma
intermediate-grade lymphoma
high-grade lymphoma
CHOP protocol
granulocyte-colony stimulating factor

Study placed in the following topic categories:

Lymphatic Diseases
Immunoproliferative Disorders
Lymphoma, small cleaved-cell, diffuse
Lymphoproliferative Disorders

Aggression
Lymphoma, Non-Hodgkin
Lymphoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on January 14, 2009