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

Primary Purpose

Non-Hodgkin's Lymphoma

Status
Terminated
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Standard CHOP
Bi-CHOP (dose intensified CHOP)
Sponsored by
Japan Clinical Oncology Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Hodgkin's Lymphoma focused on measuring Non-Hodgkin's lymphoma, intermediate-grade lymphoma, high-grade lymphoma, CHOP protocol, granulocyte-colony stimulating factor

Eligibility Criteria

15 Years - 69 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tokai University

Outcomes

Primary Outcome Measures

Progression free survival

Secondary Outcome Measures

Overall survival
Complete remission rate
Toxicity

Full Information

First Posted
August 22, 2005
Last Updated
January 17, 2007
Sponsor
Japan Clinical Oncology Group
Collaborators
Ministry of Health, Labour and Welfare, Japan
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1. Study Identification

Unique Protocol Identification Number
NCT00133302
Brief Title
Study of Standard CHOP Versus Biweekly CHOP in Aggressive Non-Hodgkin's Lymphoma (JCOG9809)
Official Title
Randomized Phase III Study of Standard CHOP (S-CHOP) Versus Biweekly CHOP (Bi-CHOP) in Aggressive Non-Hodgkin's Lymphoma (JCOG9809)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2006
Overall Recruitment Status
Terminated
Study Start Date
February 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Japan Clinical Oncology Group
Collaborators
Ministry of Health, Labour and Welfare, Japan

4. Oversight

5. Study Description

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).
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin's Lymphoma
Keywords
Non-Hodgkin's lymphoma, intermediate-grade lymphoma, high-grade lymphoma, CHOP protocol, granulocyte-colony stimulating factor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
450 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Standard CHOP
Intervention Type
Drug
Intervention Name(s)
Bi-CHOP (dose intensified CHOP)
Primary Outcome Measure Information:
Title
Progression free survival
Secondary Outcome Measure Information:
Title
Overall survival
Title
Complete remission rate
Title
Toxicity

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomomitsu Hotta, MD, PhD
Organizational Affiliation
Tokai University
Official's Role
Study Chair
Facility Information:
Facility Name
Tokai University
City
Isehara
State/Province
Kanagawa
ZIP/Postal Code
259-1193
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
21196441
Citation
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.
Results Reference
derived
Links:
URL
http://www.jcog.jp/
Description
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Study of Standard CHOP Versus Biweekly CHOP in Aggressive Non-Hodgkin's Lymphoma (JCOG9809)

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