UMIN ID: C000000036
Registered date:04/08/2005
Randomized phase III study of Standard CHOP(S-CHOP) versus Biweekly CHOP(Bi-CHOP) in aggressive Non-Hodgkin's Lymphoma(JCOG9809)
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Non-Hodgkin's lymphoma |
| Date of first enrollment | 1999/02/01 |
| Target sample size | 450 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Chemotherapy:Standard CHOP Chemotherapy:Bi-CHOP(dose intensified CHOP) |
Outcome(s)
| Primary Outcome | Progression free survival |
|---|---|
| Secondary Outcome | overall survival, complete remission rate, toxicity |
Key inclusion & exclusion criteria
| Age minimum | 15years-old |
|---|---|
| Age maximum | 69years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | (1)uncontrolable diabetes mellitus (2)severe complication (infection, heart failure, renal failure, liver failure, etc) (3)anamnesis of heart disease (4)acute or chronic hepatitis, liver chirrosis and portal hypertension (5)synchronous or metachronous malignancy (6)sever plumonary dysfunction (7)CNS invasion (8)HIV positive (9)HBs-Ag positive (10)HCV-Ab positive |
Related Information
| Primary Sponsor | Japan Clinical Oncology Group(JCOG) |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Ministry of Health, Labour and Welfare |
| Secondary ID(s) | NCT00133302 |
Contact
| public contact | |
| Name | Ken Ohmachi, MD |
| Address | 143 Simolasuya, Isehara, Kanagawa, 259-1193, Japan Japan |
| Telephone | |
| JCOG_sir@ml.jcog.jp | |
| Affiliation | JCOG9809 Coordinating Office Department of Medicine, Hematology/Oncology, Tokai university |
| scientific contact | |
| Name | Tomomitsu Hotta, MD, PhD |
| Address | 143 Simolasuya, Isehara, Kanagawa, 259-1193, Japan Japan |
| Telephone | |
| Affiliation | Tokai university Department of Medicine, Hematology/Oncology |