Clinical trial NCT00133302: Study of Standard CHOP Versus Biweekly CHOP in Aggressive Non-Hodgkin's Lymphoma (JCOG9809)
Official title: Randomized Phase III Study of Standard CHOP (S-CHOP) Versus Biweekly CHOP (Bi-CHOP) in Aggressive Non-Hodgkin's Lymphoma (JCOG9809)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Non-Hodgkin's Lymphoma
Keywords: Non-Hodgkin's lymphoma
intermediate-grade lymphoma
high-grade lymphoma
CHOP protocol
granulocyte-colony stimulating factor
Lead sponsor: Japan Clinical Oncology Group
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Labour and Welfare, Japan
First posted: 2005-08-23
Enrollment: 450
Sex: ALL
Minimum age (years): 15
Maximum age (years): 69
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Progression free survival
Secondary outcomes:
measure: Overall survival
measure: Complete remission rate
measure: Toxicity
Other outcomes:
Locations:
city: Isehara
country: Japan
facility: Tokai University
state: Kanagawa
Study officials:
affiliation: Tokai University
name: Tomomitsu Hotta, MD, PhD
role: STUDY_CHAIR
References:
citation: Ohmachi 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.