Unique ID issued by UMIN | C000000066 |
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Receipt number | R000000111 |
Scientific Title | Phase III study of VCAP-AMP-VECP vs. biweekly CHOP in aggressive adult T-cell leukemia-lymphoma (ATLL): Japan Clinical Oncology Group Study, JCOG9801. |
Date of disclosure of the study information | 2005/08/17 |
Last modified on | 2014/02/21 14:00:00 |
Phase III study of VCAP-AMP-VECP vs. biweekly CHOP in aggressive adult T-cell leukemia-lymphoma (ATLL): Japan Clinical Oncology Group Study, JCOG9801.
Phase III study of VCAP-AMP-VECP vs. biweekly CHOP in aggressive adult T-cell leukemia-lymphoma (ATLL): Japan Clinical Oncology Group Study, JCOG9801.
Phase III study of VCAP-AMP-VECP vs. biweekly CHOP in aggressive adult T-cell leukemia-lymphoma (ATLL): Japan Clinical Oncology Group Study, JCOG9801.
Phase III study of VCAP-AMP-VECP vs. biweekly CHOP in aggressive adult T-cell leukemia-lymphoma (ATLL): Japan Clinical Oncology Group Study, JCOG9801.
Japan |
adult T-cell leukemia / lymphoma
Hematology and clinical oncology |
Malignancy
NO
To test the superiority of VCAP-AMP-VECP regimen over biweekly-CHOP in aggressive ATLL in terms of survival benefit.
Efficacy
Confirmatory
Phase III
Overall survival
Toxicity, CR rate, Progression free survival
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
YES
Institution is considered as adjustment factor in dynamic allocation.
NO
Central registration
2
Treatment
Medicine |
VCAP-AMP-VECP with G-CSF and intrathecal prophylaxis.
biweekly-CHOP with G-CSF and intrathecal prophylaxis.
15 | years-old | <= |
70 | years-old | > |
Male and Female
1) Diagnosis of ATL was made based on seropositivity for HTLV-I by either enzyme-linked immunosorbent assay or particle agglutination assay, and histologically- and/or cytologically-proven peripheral T-cell malignancy.
2) Aggressive ATL, i.e., acute-, lymphoma- or unfavorable chronic-type ATL.
3) Aged 15-69 years.
4) No prior chemotherapy or radiotherapy.
5) Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-3 or 4 as a result of hypercalcemia.
6) Preserved organ (bone marrow, liver, kidney, heart and lung) functons.
7) All patients were required to provide written informed consent.
1) Diabetes mellitus necessitating treatment with insulin.
2) Active systemic infection.
3) Cardiac disorders expected to become worse as a result of the DOX-containing regimen.
4) Acute hepatitis, chronic hepatitis or liver rrhosis.
5) Positive for HBs Ag or anti-HCV Ab.
6) Active concurrent malignancy.
7) Other serious medical or psychiatric conditions.
8) Pregnancy or breast feeding.
9) Central nervous system involvement by ATL cells.
130
1st name | |
Middle name | |
Last name | Masao Tomonaga, MD, PhD |
Nagasaki University Graduate School of Biomedical Science
Department of Hematology
1-12-4 Sakamoto, Nagasaki 852-8523, Japan
1st name | |
Middle name | |
Last name | Kunihiro Tsukasaki, MD, PhD |
JCOG9801 Coordinating Office
Department of Hematology, Nagasaki University Graduate School of Biomedical Science
1-12-4 Sakamoto, Nagasaki 852-8523, Japan
http://www.jcog.jp/
JCOG_sir@ml.jcog.jp
Japan Clinical Oncology Group(JCOG)
Ministry of Health, Labour and Welfare
J
YES
NCT00145002
ClinicalTrials.gov by NLM
2005 | Year | 08 | Month | 17 | Day |
Published
http://www.ncbi.nlm.nih.gov/pubmed/17968021
See the datails via "URL releasing results" above.
Also the details can be seen in the JCOG website:
http://www.jcog.jp/en/trials/index.html
Completed
1998 | Year | 05 | Month | 15 | Day |
1998 | Year | 08 | Month | 01 | Day |
2004 | Year | 12 | Month | 01 | Day |
2005 | Year | 02 | Month | 01 | Day |
2005 | Year | 02 | Month | 01 | Day |
2005 | Year | 02 | Month | 01 | Day |
2005 | Year | 08 | Month | 17 | Day |
2014 | Year | 02 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000111
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