Rituximab+Standard CHOP vs Rituximab+bi-Weekly CHOP for Untreated Stage III/IV Low-Grade B-Cell Lymphoma (JCOG0203)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified February 2009 by Japan Clinical Oncology Group.
Recruitment status was Active, not recruiting

Sponsor:

Collaborator:

Ministry of Health, Labour and Welfare, Japan

Information provided by:

Japan Clinical Oncology Group

ClinicalTrials.gov Identifier:

NCT00147121

First received: September 5, 2005

Last updated: February 2, 2009

Last verified: February 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

September 5, 2005

Last Updated Date

February 2, 2009

Start Date ^ICMJE

September 2002

Estimated Primary Completion Date

February 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

CR rate (phase II) [ Time Frame: during the study conduct ] [ Designated as safety issue: No ]
PFS (phase III) [ Time Frame: during the study conduct ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

CR rate (phase II)
PFS (phase III)

Change History

Complete list of historical versions of study NCT00147121 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

ORR, PFS, OS, Safety (phase II) [ Time Frame: during the study conduct ] [ Designated as safety issue: Yes ]
OS, Safety (phase III) [ Time Frame: during the study conduct ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

ORR, PFS, OS, Safety (phase II)
OS, Safety (phase III)

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Rituximab+Standard CHOP vs Rituximab+bi-Weekly CHOP for Untreated Stage III/IV Low-Grade B-Cell Lymphoma (JCOG0203)

Official Title ^ICMJE

Rituximab + Standard CHOP (R･S-CHOP) vs Rituximab+ bi-Weekly CHOP (R･Bi-CHOP) RCT(Phase II/III) for Stage III/IV Low-Grade B-Cell Lymphoma (LowBNHL-RS/BiCHOP-P2/3) (JCOG0203)

Brief Summary

To establish standard therapy for patients with advanced-stage low grade B-cell lymphoma

Detailed Description

Since currently there is no standard therapy for untreated advanced-stage low-grade B-cell lymphoma, Phase 2/3 study was planned. Comparison(s): An intensified bi-weekly version by shortening the intervals of both rituximab and CHOP therapies using G-CSF, compared to the tri-weekly R-CHOP regimen.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Lymphoma, B-Cell

Intervention ^ICMJE

Drug: Rituximab + Standard CHOP
Rituximab + Standard CHOP
Drug: Rituximab + Bi-weekly CHOP
Rituximab + Bi-weekly CHOP

Study Arm (s)

Active Comparator: 1
Rituximab+Standard CHOP

Intervention: Drug: Rituximab + Standard CHOP
Experimental: 2
Rituximab+bi-Weekly CHOP

Intervention: Drug: Rituximab + Bi-weekly CHOP

Publications *

Watanabe T, Tobinai K, Shibata T, Tsukasaki K, Morishima Y, Maseki N, Kinoshita T, Suzuki T, Yamaguchi M, Ando K, Ogura M, Taniwaki M, Uike N, Takeuchi K, Nawano S, Terauchi T, Hotta T. Phase II/III study of R-CHOP-21 versus R-CHOP-14 for untreated indolent B-cell non-Hodgkin's lymphoma: JCOG 0203 trial. J Clin Oncol. 2011 Oct 20;29(30):3990-8. Epub 2011 Sep 19.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

300

Estimated Completion Date

February 2010

Estimated Primary Completion Date

February 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Histological confirmed, low-grade B-cell lymphoma except mantle cell lymphoma and histologic transformation to DLBCL
CD20-positive
Ann Arbor CS III or IV
Lymphoma cell count in PB≦10,000/mm3
20<=age<=69
ECOG PS 0-2
Bidimensionally measurable disease >1.5cm in a single dimension by CT scans
No prior chemotherapy, radiotherapy, interferon-alfa, or antibody therapy
Normal BM, hepatic, renal, cardiac, and pulmonary function
Written informed consent

Exclusion Criteria:

CNS involvement
Glaucoma
DM treated by insulin
Uncontrollable HT
AP, AMI
Positive HBs antigen
seropositive to HCV
seropositive to HIV
Interstitial pneumonitis, pulmonary fibrosis, or emphysema
Severe infection
Liver cirrhosis
Double cancer
Pregnant or lactating
Patients who desire auto PBST after CR
Patients treated with major tranquilizer or antidepressant

Gender

Both

Ages

20 Years to 69 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT Number ^ICMJE

NCT00147121

Other Study ID Numbers ^ICMJE

JCOG0203, C000000033

Has Data Monitoring Committee

Yes

Responsible Party

Japan Clinical Oncology Group

Study Sponsor ^ICMJE

Japan Clinical Oncology Group

Collaborators ^ICMJE

Ministry of Health, Labour and Welfare, Japan

Investigators ^ICMJE

Study Chair:

Kensei Tobinai, M.D.,Ph.D.

National Cancer Center Hospital

Information Provided By

Japan Clinical Oncology Group

Verification Date

February 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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