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

Phase 3
15 Years
69 Years
Not Enrolling
Non-Hodgkin's Lymphoma

Thank you

Trial Information

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

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).

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

Type of Study:


Study Design:

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

Outcome Measure:

Progression free survival

Principal Investigator

Tomomitsu Hotta, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Tokai University


Japan: Ministry of Health, Labor and Welfare

Study ID:




Start Date:

February 1999

Completion Date:

February 2005

Related Keywords:

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