Study of Standard CHOP Versus Biweekly CHOP in Aggressive Non-Hodgkin's Lymphoma (JCOG9809)

Phase 3TerminatedNCT00133302

Japan Clinical Oncology Group450 enrolled

Overview

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).

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

450

Conditions

Non-Hodgkin's Lymphoma

Interventions

Standard CHOPDRUG

Bi-CHOP (dose intensified CHOP)DRUG

Eligibility

Sex: ALLMin age: 15 YearsMax age: 69 Years

Medical Language ↔ Plain English

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

Locations (1)

Tokai University

Isehara, Kanagawa, Japan

Outcomes

Primary Outcomes

Progression free survival

Secondary Outcomes

Overall survival

Complete remission rate

Toxicity

Data from ClinicalTrials.gov

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