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

This study has been terminated.
Ministry of Health, Labour and Welfare, Japan
Information provided by:
Japan Clinical Oncology Group Identifier:
First received: August 22, 2005
Last updated: January 17, 2007
Last verified: August 2006
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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Phase III Study of Standard CHOP (S-CHOP) Versus Biweekly CHOP (Bi-CHOP) in Aggressive Non-Hodgkin's Lymphoma (JCOG9809)

Resource links provided by NLM:

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).

Ages Eligible for Study:   15 Years to 69 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00133302

Tokai University
Isehara, Kanagawa, Japan, 259-1193
Sponsors and Collaborators
Japan Clinical Oncology Group
Ministry of Health, Labour and Welfare, Japan
Study Chair: Tomomitsu Hotta, MD, PhD Tokai University
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00133302     History of Changes
Other Study ID Numbers: JCOG9809
Study First Received: August 22, 2005
Last Updated: January 17, 2007

Keywords provided by Japan Clinical Oncology Group:
Non-Hodgkin's lymphoma
intermediate-grade lymphoma
high-grade lymphoma
CHOP protocol
granulocyte-colony stimulating factor

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases processed this record on July 19, 2017