UMIN-CTR Clinical Trial

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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