UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000092
Receipt number 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 14:08:18

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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 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 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

Value
https://center6.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