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

Non-Hodgkin's Lymphoma Clinical Trial

Official title:

Randomized Phase III Study of Standard CHOP (S-CHOP) Versus Biweekly CHOP (Bi-CHOP) in Aggressive Non-Hodgkin's Lymphoma (JCOG9809)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00133302
• Other study ID #: JCOG9809
• Secondary ID: C000000036
• Status: Terminated
• Phase: Phase 3
• First received: August 22, 2005
• Last updated: January 17, 2007
• Start date: February 1999
• Est. completion date: February 2005

Study information

• Verified date: August 2006
• Source: Japan Clinical Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 450
• Est. completion date: February 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 69 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Non-Hodgkin's Lymphoma

Intervention

Drug:
• Standard CHOP

• Bi-CHOP (dose intensified CHOP)

Locations

Country	Name	City	State
Japan	Tokai University	Isehara	Kanagawa

Sponsors (2)

Lead Sponsor	Collaborator
Japan Clinical Oncology Group	Ministry of Health, Labour and Welfare, Japan

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival
Secondary	Overall survival
Secondary	Complete remission rate
Secondary	Toxicity

External Links

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