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

This study has been terminated.
Sponsor:
Collaborator:
Ministry of Health, Labour and Welfare, Japan
Information provided by:
Japan Clinical Oncology Group
ClinicalTrials.gov Identifier:
NCT00133302
First received: August 22, 2005
Last updated: January 17, 2007
Last verified: August 2006
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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).

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Additional Information:
No publications provided by Japan Clinical Oncology Group

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00133302     History of Changes
Other Study ID Numbers: JCOG9809, C000000036
Study First Received: August 22, 2005
Last Updated: January 17, 2007
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

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 27, 2014