UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN C000000033
Receipt No. R000000069
Scientific Title Rituximab + standard CHOP (R S-CHOP) vs Rituximab + bi-weekly CHOP (R Bi-CHOP) RCT(phase II/III) low-grade B-cell lymphoma at advanced stage (LowBNHL-RS/BiCHOP-P2/3) (JCOG0203)
Date of disclosure of the study information 2005/07/30
Last modified on 2014/04/30

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Rituximab + standard CHOP (R S-CHOP) vs Rituximab + bi-weekly CHOP (R Bi-CHOP) RCT(phase II/III) low-grade B-cell lymphoma at advanced stage (LowBNHL-RS/BiCHOP-P2/3) (JCOG0203)
Acronym Rituximab + standard CHOP vs Rituximab + bi-weekly CHOP for untreated low-grade B-cell lymphoma at advanced stage (JCOG0203)
Scientific Title Rituximab + standard CHOP (R S-CHOP) vs Rituximab + bi-weekly CHOP (R Bi-CHOP) RCT(phase II/III) low-grade B-cell lymphoma at advanced stage (LowBNHL-RS/BiCHOP-P2/3) (JCOG0203)
Scientific Title:Acronym Rituximab + standard CHOP vs Rituximab + bi-weekly CHOP for untreated low-grade B-cell lymphoma at advanced stage (JCOG0203)
Region
Japan

Condition
Condition Untreated CD20-positive low-grade B-cell lymphoma at advanced stage
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To establish standard therapy for patients with advanced-stage low grade B-cell lymphoma
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II,III

Assessment
Primary outcomes CR rate (phase II), PFS (phase III)
Key secondary outcomes ORR, PFS, OS, Safety (phase II), OS, Safety (phase III)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Rituximab + Standard CHOP
Interventions/Control_2 Rituximab + Bi-weekly CHOP
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
69 years-old >=
Gender Male and Female
Key inclusion criteria (1) Histological confirmed, low-grade B-cell lymphoma except mantle cell lymphoma and histologic transformation to DLBCL
(2) CD20-positive
(3) Ann Arbor CS III or IV
(4) Lymphoma cell count in PB<=10,000/mm3
(5) 20<=age<=69
(6) ECOG PS 0-2
(7) Bidimensionally measurable disease >1.5cm in a single dimention by CT scans
(8) No prior chemotherapy, radiotherapy, interferon-alfa, or antibody therapy
(9) Normal BM, hepatic, renal, cardiac, and pulmonary function
(10) Written informed consent
Key exclusion criteria (1) CNS involvement
(2) Glaucoma
(3) DM treated by insulin
(4) Uncontrolable HT
(5) AP, AMI
(6) Positive HBs antigen
(7) seropositive to HCV
(8) seropositive to HIV
(9) Interstitial pneumonitis, pulmonary fibrosis, or emphysema
(10) Severe infection
(11) Liver cirrhosis
(12) Double cancer
(13) Pregnant or lactating
(14) Patients who desire auto PBST after CR
(15) Patients treated with major tranquilizer or antidepressant
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kensei Tobinai, M.D.,Ph.D.
Organization National Cancer Center Hospital
Division name Hematology Division
Zip code
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, JAPAN
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Watanabe, M.D.,Ph.D.
Organization JCOG0203 Coordinating Office
Division name Hematology Division, National Cancer Center Hospital
Zip code
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, JAPAN
TEL
Homepage URL http://www.jcog.jp/
Email JCOG_sir@ml.jcog.jp

Sponsor
Institute Japan Clinical Oncology Group(JCOG)
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 NCT00147121
Org. issuing International ID_1 ClinicalTrials.gov by NLM
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 国立病院機構北海道がんセンター(北海道)
札幌北楡病院内科(北海道)
東北大学病院(宮城県)
秋田大学医学部(秋田県)
太田西ノ内病院(群馬県)
群馬大学医学部附属病院(群馬県)
埼玉県立がんセンター(埼玉県)
国立がん研究センター東病院(千葉県)
千葉県がんセンター(千葉県)
国立がん研究センター中央病院(東京都)
杏林大学医学部(東京都)
東京医科大学病院(東京都)
がん・感染症センター都立駒込病院(東京都)
東京慈恵会医科大学附属病院(東京都)
東京慈恵会医科大学青戸病院(東京都)
東京慈恵会医科大学第三病院(東京都)
東海大学医学部(神奈川県)
聖マリアンナ医科大学横浜市西部病院(神奈川県)
新潟県立がんセンター新潟病院(新潟県)
金沢医科大学(石川県)
福井大学医学部附属病院(福井県)
福井県立病院(福井県)
福井赤十字病院(福井県)
浜松医科大学(静岡県)
愛知県がんセンター中央病院(愛知県)
国立病院機構名古屋医療センター(愛知県)
名古屋大学医学部(愛知県)
名古屋市立大学病院(愛知県)
名古屋第二赤十字病院(愛知県)
愛知医科大学附属病院(愛知県)
三重大学医学部(三重県)
滋賀県立成人病センター(滋賀県)
大津赤十字病院(滋賀県)
京都府立医科大学(京都府)
関西医科大学(大阪府)
近畿大学医学部(大阪府)
国立病院機構四国がんセンター(愛媛県)
愛媛大学医学部附属病院第一内科(愛媛県)
国立病院機構九州がんセンター(福岡県)
福岡大学医学部(福岡県)
国立病院機構九州医療センター(福岡県)
産業医科大学(福岡県)
佐賀大学医学部血液内科(佐賀県)
国立病院機構長崎医療センター(長崎県)
佐世保市立総合病院(長崎県)
長崎大学病院(長崎県)
熊本大学医学部(熊本県)
国立病院機構熊本医療センター(熊本県)
大分県立病院(大分県)
鹿児島大学医学部・歯学部附属病院(鹿児島県)
今村病院分院内科(鹿児島県)
琉球大学医学部(沖縄県)


Other administrative information
Date of disclosure of the study information
2005 Year 07 Month 30 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/21931035
Number of participants that the trial has enrolled
Results
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
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2002 Year 07 Month 19 Day
Date of IRB
Anticipated trial start date
2002 Year 09 Month 01 Day
Last follow-up date
2022 Year 02 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2005 Year 07 Month 30 Day
Last modified on
2014 Year 04 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000069

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.