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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000000929
Receipt No. R000001100
Scientific Title Randomized phase II/III study of R-CHOP versus weekly rituximab plus CHOP for CD20 positive diffuse large B cell lymphoma (JCOG0601)
Date of disclosure of the study information 2007/12/04
Last modified on 2014/12/26

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Basic information
Public title Randomized phase II/III study of R-CHOP versus weekly rituximab plus CHOP for CD20 positive diffuse large B cell lymphoma (JCOG0601)
Acronym Randomized phase II/III study of R-CHOP versus weekly rituximab plus CHOP for CD20 positive diffuse large B cell lymphoma (JCOG0601)
Scientific Title Randomized phase II/III study of R-CHOP versus weekly rituximab plus CHOP for CD20 positive diffuse large B cell lymphoma (JCOG0601)
Scientific Title:Acronym Randomized phase II/III study of R-CHOP versus weekly rituximab plus CHOP for CD20 positive diffuse large B cell lymphoma (JCOG0601)
Region
Japan

Condition
Condition CD20 positive diffuse large B cell lmyphoma
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The objective of this trial is to investigate clinical benefit of raising a serum concentration of rituximab in R-CHOP for CD20 positive diffuse large 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 phaseII : complete response rate
phaseIII : progression free survival
Key secondary outcomes phaseII : progression free survival, overall survival, adverse events, seriouse adverse events
phaseIII : overall survival, adverse events, seriouse adverse events

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 A:R-CHOP
Interventions/Control_2 B:RW+CHOP(weekly rituximab plus 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
79 years-old >=
Gender Male and Female
Key inclusion criteria (1)CD20 positive diffuse large B-cell lymphoma (WHO classification), excluding histological transformation form marginal zone B cell lymphoma or follicular lymphoma and immunodeficiency associated lymphoproliferative disorders.
(2) lymphoma with CD20 positive by immunohistochemistry or flow cytometry
(3)clinical staging is evaluated by diagnostic imaging procedures within 28 days before entry.
(4)stage I disease without bulky mass inappropriate for chemo-radiotherapy
(5)lymphoma cells in peripheral blood: no more than 10000/mm3
(6)Performance Status: 0-2
(7)no CNS invasion
(8)having measurable lesion
(9)no prior chemotherapy, radiotherapy and anti-body therapy
(10)WBC: more than 3000/mm3
(11)neutrophil: more than 1000/mm3
(12)platlets: more than 10x104/mm3
(13)AST: no more than 150 U/L
(14)ALT: male: no more than 210 U/L
female: no more than 115 U/L
(15)T-bil: no more than 2.0mg/dl
(16)creatinine: no more than 2.0mg/dl
(17)normal ECG
(18)ejection fraction: more than 50%
(19)PaO2: more than 65mmHg(room air)
(20)written informed consent
Key exclusion criteria (1)anamnesis of graucoma
(2)diabetes mellitus treating insulin or uncontrolled
(3)uncontrollable hypertension
(4)coronary artery necessary, cardiomyopathy and heart failure necessary treatment, arrhythmia treating antiarrhyshmic
(5)HBs-Ag positive
(6)HCV positive
(7)HIV positive
(8)interstitial pneumonia, plumonary fiblosis
(9)severe infection
(10)synchronous or metachronous malignancy
(11)pregnant/lactating woman
(12)psychosis
(13)given systemic steroid
Target sample size 422

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomohiro Kinoshita
Organization Aichi Cancer Center Hospital
Division name Department of Hematology and Cell Therapy
Zip code
Address 1-1 Kanokoden, Chikusa-ku Nagoya 464-8681, Japan
TEL 052-762-6111
Email kinosita@aichi-cc.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ken Ohmachi
Organization JCOG0601 Coordinating Office
Division name Tokai University, Division of Hematology Oncology
Zip code
Address 143 shimokasuya, Isehara, Kanagawa, 259-1193, JAPAN
TEL 0463-93-1121
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 NO
Study ID_1
Org. issuing International ID_1
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(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(福島県)
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)
埼玉医科大学総合医療センター(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)
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第三病院(東京都)
がん研究会有明病院(東京都)
NTT東日本関東病院(東京都)
東海大学医学部(神奈川県)
金沢医科大学(石川県)
福井大学医学部附属病院(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)
豊田厚生病院(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)
京都府立医科大学(京都府)
兵庫県立がんセンター(兵庫県)
岡山医療センター(岡山県)
広島大学病院(広島県)
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(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(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(鹿児島県)
琉球大学医学部附属病院(沖縄県)

Other administrative information
Date of disclosure of the study information
2007 Year 12 Month 04 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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 No longer recruiting
Date of protocol fixation
2007 Year 10 Month 18 Day
Date of IRB
Anticipated trial start date
2007 Year 12 Month 04 Day
Last follow-up date
2017 Year 12 Month 04 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2007 Year 12 Month 04 Day
Last modified on
2014 Year 12 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001100

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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