Clinical trial · Interventional
Study of Standard CHOP Versus Biweekly CHOP in Aggressive Non-Hodgkin's Lymphoma (JCOG9809)
Randomized Phase III Study of Standard CHOP (S-CHOP) Versus Biweekly CHOP (Bi-CHOP) in Aggressive Non-Hodgkin's Lymphoma (JCOG9809)
NCT00133302CI-TRIAL-00000564terminatedPhase 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)
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).
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 |
|---|---|---|---|
| Non-Hodgkin's Lymphoma | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bi-CHOP (dose intensified CHOP) | Drug | — | UNRESOLVED |
| Standard CHOP | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Progression free survival
Secondary outcomes (3)
- measure
- Overall survival
- measure
- Complete remission rate
- measure
- Toxicity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
- Maximum age
- 69 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDOhmachi 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. PMID 21196441