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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000092
Receipt No. R000000140
Scientific Title Phase II study of ABVd therapy for the previously untreated patients with stage II to IV Hodgkin' s disease (JCOG 9305, LSG14)
Date of disclosure of the study information 2005/08/30
Last modified on 2014/02/21

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Basic information
Public title Phase II study of ABVd therapy for the previously untreated patients with stage II to IV Hodgkin' s disease (JCOG 9305, LSG14)
Acronym Phase II study of ABVd therapy for the previously untreated patients with stage II to IV Hodgkin' s disease (JCOG 9305, LSG14)
Scientific Title Phase II study of ABVd therapy for the previously untreated patients with stage II to IV Hodgkin' s disease (JCOG 9305, LSG14)
Scientific Title:Acronym Phase II study of ABVd therapy for the previously untreated patients with stage II to IV Hodgkin' s disease (JCOG 9305, LSG14)
Region
Japan

Condition
Condition previouly untreated advanced stage Hodgkin lymphoma (stage II, III, IVy)
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy and toxicity of ABVd therapy, and to compare ABVd therapy with C-MOPP-ABVd therapy and with ABVD therapy historically against advanced Hodgkin lymphoma.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes complete response rate (%CR+%Cru), progression-free survival
Key secondary outcomes toxicity, 5-year surivival, prognostic foctor

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 Maneuver
Interventions/Control_1 polychemotherapy, raiotheraoy
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

Not applicable
Age-upper limit
70 years-old >
Gender Male and Female
Key inclusion criteria (1) Biopsy-proven Hodgkin lymphoma
(2) Clinical stage II, III or IV
(3) PS 0-3 (ECOG)
(3) No severe organ dysfunction
(4) Age < 70
(5) Previously untreated
(6) With evaluable lesions
(7) Written informed consent

Key exclusion criteria 1.severe comorbidity (e.g. severe infectious disease, heart failure, respiratory dysfunction, hepatic failure, liver cirrhosis, renal failure, active peptic ulcer, insulin dependent diabetes mellitus
2. other active neoplasms
3. psychological disease
4. expected survival ; less than 3 months
5. Pregnant women
6. Past history of myocardial infarction
7. Positive for HTLV-1

Target sample size 108

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masanori Shimoyama, MD, PhD
Organization National Cancer Center Hospital
Division name Department of Medical Oncology
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 Michinori Ogura, MD, PhD
Organization JCOG9305 Coordinating Office
Division name Department of Hematology, Nagoya Daini Red Cross Hospital
Zip code
Address Myokencho 2-9, Showaku, Nagoya, Aichi 466-8650, 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 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 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/21076995
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
1993 Year 11 Month 08 Day
Date of IRB
Anticipated trial start date
1993 Year 12 Month 01 Day
Last follow-up date
2002 Year 06 Month 01 Day
Date of closure to data entry
2003 Year 09 Month 01 Day
Date trial data considered complete
2003 Year 09 Month 01 Day
Date analysis concluded
2004 Year 07 Month 01 Day

Other
Other related information

Management information
Registered date
2005 Year 08 Month 30 Day
Last modified on
2014 Year 02 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000140

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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