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)

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00133302

Enrollment

450

Registered

2005-08-23

Start date

1999-02-28

Completion date

2005-02-28

Last updated

2007-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Hodgkin's Lymphoma

Keywords

Non-Hodgkin's lymphoma, intermediate-grade lymphoma, high-grade lymphoma, CHOP protocol, granulocyte-colony stimulating factor

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).

Interventions

DRUGStandard CHOP

DRUGBi-CHOP (dose intensified CHOP)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

15 Years to 69 Years

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

Design outcomes

Primary

Measure	Time frame
Progression free survival	—

Secondary

Measure	Time frame
Overall survival	—
Complete remission rate	—
Toxicity	—

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026