UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000053
Receipt number R000000098
Scientific Title CHOP therapy for low and low-intermediate risk patients of advanced aggressive non-Hodgkin's lymphoma (JCOG9508, LSG17(CHOP))
Date of disclosure of the study information 2005/08/09
Last modified on 2014/02/21 13:52:43

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Basic information

Public title

CHOP therapy for low and low-intermediate risk patients of advanced aggressive non-Hodgkin's lymphoma (JCOG9508, LSG17(CHOP))

Acronym

CHOP therapy for low and low-intermediate risk patients of advanced aggressive non-Hodgkin's lymphoma (JCOG9508, LSG17(CHOP))

Scientific Title

CHOP therapy for low and low-intermediate risk patients of advanced aggressive non-Hodgkin's lymphoma (JCOG9508, LSG17(CHOP))

Scientific Title:Acronym

CHOP therapy for low and low-intermediate risk patients of advanced aggressive non-Hodgkin's lymphoma (JCOG9508, LSG17(CHOP))

Region

Japan


Condition

Condition

low and low-intermediate risk of aggressive non-Hodgkin's lymphoma

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the survival rate of CHOP hterapy for low and low-intermediate risk of aggressive non-Hodgkin's lymphoma

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

overall survival

Key secondary outcomes

Complete remission rate, Progression free survaval, adverse reaction/adverse effect


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Chemotherapy (8 courses of CHOP)

Interventions/Control_2


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

15 years-old <=

Age-upper limit

70 years-old >

Gender

Male and Female

Key inclusion criteria

(1) histologically diagnosed non-Hodgkin's lymphoma with intermediate or high grade by Working Formulation, except for transformation from low grade lymphoma, ATL, T-lymphoblastic lymphoma, mycosis fungoideus, and Sezary syndrome.
(2) Clinical stage of I-bulky, II, III, IV by Ann Arbor classification.
(3) No previous chemotherapy or radiotherapy.
(4) Age: between 15 and 69.
(5) Performance Status: between 0 and 3.
(6) Low or low-intermediate risk by International index
(7) No organ dysfuction; neutrophil count>1200/ml, platelet count >75000/ml, ASTand ALT level <5 times the upper limit of the normal range, total bilirubin level < 2.0 mg/dl, serum creatinin level < 2.0mg/dl, no cardiac dysfunction.
(8) Understanding and agreement of written informed consent.

Key exclusion criteria

1) Complication; severe infection, heart failure, respiratory failure, hepatic failure, organic pulumonary disease, liver cirrhosis, acute or chronic hepatitis, renal failure.
2) Active or non-curable synchronous malignancy, except for cervical carcinoma in situ or basal carcinoma of the skin.
3) Psycological disorder like schizophrenia.
4) Heart disease which is deteriorated by anthracyclins, past history of myocardial infarction, or angina pectoris during 3 months before registration.
5) Pregnant or nursing .
6) Involvement of central nervous system
7) HIV infection

Target sample size

160


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Michinori Ogura, MD, PhD

Organization

Nagoya Daini Red-cross Hospital

Division name

Department of Hematology

Zip code


Address

2-9 myouken-cho, Shouwa-ku, Nagoya, JAPAN

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Yoshitoyo Kagami, MD, PhD

Organization

JCOG9508 Coordinating Office

Division name

Department of Hematology and Cell-therapy, Aichi Cancer Center Hospital

Zip code


Address

1-1 Kanokoden, Chikusa-ku, Nagoya, 464-8681, JAPAN

TEL


Homepage URL

http://www.jcog.jp/

Email

JCOG_sir@ml.jcog.jp


Sponsor or person

Institute

Japan Clinical Oncology Group(JCOG)

Institute

Department

Personal name



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



Other administrative information

Date of disclosure of the study information

2005 Year 08 Month 09 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://www.ncbi.nlm.nih.gov/pubmed/22661011

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

Completed

Date of protocol fixation

1995 Year 04 Month 19 Day

Date of IRB


Anticipated trial start date

1995 Year 06 Month 01 Day

Last follow-up date

2004 Year 07 Month 01 Day

Date of closure to data entry

2004 Year 08 Month 01 Day

Date trial data considered complete

2004 Year 08 Month 01 Day

Date analysis concluded

2005 Year 01 Month 01 Day


Other

Other related information



Management information

Registered date

2005 Year 08 Month 09 Day

Last modified on

2014 Year 02 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000098


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name