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Rituximab+Standard CHOP vs Rituximab+Bi-weekly CHOP for Untreated Stage III/IV Low-grade B-cell Lymphoma (JCOG0203)

This study has been completed.
Ministry of Health, Labour and Welfare, Japan
Information provided by (Responsible Party):
Haruhiko Fukuda, Japan Clinical Oncology Group Identifier:
First received: September 5, 2005
Last updated: September 20, 2016
Last verified: September 2016

September 5, 2005
September 20, 2016
September 2002
February 2010   (Final data collection date for primary outcome measure)
  • CR rate (phase II) [ Time Frame: during the study conduct ]
  • PFS (phase III) [ Time Frame: during the study conduct ]
  • CR rate (phase II)
  • PFS (phase III)
Complete list of historical versions of study NCT00147121 on Archive Site
  • ORR, PFS, OS, Safety (phase II) [ Time Frame: during the study conduct ]
  • OS, Safety (phase III) [ Time Frame: during the study conduct ]
  • ORR, PFS, OS, Safety (phase II)
  • OS, Safety (phase III)
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Rituximab+Standard CHOP vs Rituximab+Bi-weekly CHOP for Untreated Stage III/IV Low-grade B-cell Lymphoma (JCOG0203)
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)
To establish standard therapy for patients with advanced-stage low grade B-cell lymphoma
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.
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Lymphoma, B-Cell
  • Drug: Rituximab + Standard CHOP
    Rituximab + Standard CHOP
  • Drug: Rituximab + Bi-weekly CHOP
    Rituximab + Bi-weekly CHOP
  • Active Comparator: 1
    Rituximab+Standard CHOP
    Intervention: Drug: Rituximab + Standard CHOP
  • Experimental: 2
    Rituximab+bi-Weekly CHOP
    Intervention: Drug: Rituximab + Bi-weekly CHOP
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. doi: 10.1200/JCO.2011.34.8508. Epub 2011 Sep 19.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
February 2010
February 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Histological confirmed, low-grade B-cell lymphoma except mantle cell lymphoma and histologic transformation to DLBCL
  2. CD20-positive
  3. Ann Arbor CS III or IV
  4. Lymphoma cell count in PB≦10,000/mm3
  5. 20<=age<=69
  6. ECOG PS 0-2
  7. Bidimensionally measurable disease >1.5cm in a single dimension by CT scans
  8. No prior chemotherapy, radiotherapy, interferon-alfa, or antibody therapy
  9. Normal BM, hepatic, renal, cardiac, and pulmonary function
  10. Written informed consent

Exclusion Criteria:

  1. CNS involvement
  2. Glaucoma
  3. DM treated by insulin
  4. Uncontrollable HT
  5. AP, AMI
  6. Positive HBs antigen
  7. seropositive to HCV
  8. seropositive to HIV
  9. Interstitial pneumonitis, pulmonary fibrosis, or emphysema
  10. Severe infection
  11. Liver cirrhosis
  12. Double cancer
  13. Pregnant or lactating
  14. Patients who desire auto PBST after CR
  15. Patients treated with major tranquilizer or antidepressant
Sexes Eligible for Study: All
20 Years to 69 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
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Haruhiko Fukuda, Japan Clinical Oncology Group
Haruhiko Fukuda
Ministry of Health, Labour and Welfare, Japan
Study Chair: Kensei Tobinai, M.D.,Ph.D. National Cancer Center Hospital
Japan Clinical Oncology Group
September 2016

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