Clinical trial · Interventional
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)
NCT00147121CI-TRIAL-00024000completedPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To establish standard therapy for patients with advanced-stage low grade B-cell lymphoma
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma, B-Cell | B-Cell Malignant Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Rituximab + Bi-weekly CHOP | Drug | — | UNRESOLVED |
| Rituximab + Standard CHOP | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- Rituximab+Standard CHOP
- interventionNames
- Drug: Rituximab + Standard CHOP
- type
- EXPERIMENTAL
- label
- 2
- description
- Rituximab+bi-Weekly CHOP
- interventionNames
- Drug: Rituximab + Bi-weekly CHOP
Primary outcomes (2)
- measure
- CR rate (phase II)
- timeFrame
- during the study conduct
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 69 Years
Show eligibility criteria text
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
References
Publications (3)
- DERIVEDWatanabe T, Tobinai K, Wakabayashi M, Maruyama D, Yamamoto K, Kubota N, Shimada K, Asagoe K, Yamaguchi M, Ando K, Ogura M, Kuroda J, Suehiro Y, Matsuno Y, Tsukasaki K, Nagai H. R-CHOP treatment for patients with advanced follicular lymphoma: Over 15-year follow-up of JCOG0203. Br J Haematol. 2024 Mar;204(3):849-860. doi: 10.1111/bjh.19213. Epub 2023 Nov 23. PMID 37996986
- DERIVEDWatanabe T, Tobinai K, Wakabayashi M, Morishima Y, Kobayashi H, Kinoshita T, Suzuki T, Yamaguchi M, Ando K, Ogura M, Taniwaki M, Uike N, Yoshino T, Nawano S, Terauchi T, Hotta T, Nagai H, Tsukasaki K; JCOG0203 Collaborators. Outcomes after R-CHOP in patients with newly diagnosed advanced follicular lymphoma: a 10-year follow-up analysis of the JCOG0203 trial. Lancet Haematol. 2018 Nov;5(11):e520-e531. doi: 10.1016/S2352-3026(18)30155-8. PMID 30389034
- DERIVEDWatanabe 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. PMID 21931035