UMIN-CTR Clinical Trial

Unique ID issued by UMIN	C000000068
Receipt number	R000000113
Scientific Title	Phase II study of ABV with increased dose of adriamycin (ADM) and deleted DTIC followed by adjuvant involved-field radiotherapy (ABV/IFRT) to residual or initial bulky tumor for the previously untreated patients with advanced Hodgkin's disease (stage IB, IIB, III, IV or bulky). (JCOG9705)
Date of disclosure of the study information	2005/08/18
Last modified on	2014/02/21 14:02:47

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Basic information

Public title

Phase II study of ABV with increased dose of adriamycin (ADM) and deleted DTIC followed by adjuvant involved-field radiotherapy (ABV/IFRT) to residual or initial bulky tumor for the previously untreated patients with advanced Hodgkin's disease (stage IB, IIB, III, IV or bulky). (JCOG9705)

Acronym

Scientific Title

Scientific Title:Acronym

Region

Japan

Condition

previouly untreated advanced stage Hodgkin lymphoma (stage IB, IIB, III, IV, or bulky)

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

Objectives

Narrative objectives1

To explore a less toxic and equally effective chemotherapy regimen against advanced Hodgkin lymphoma.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Phase II

Assessment

Primary outcomes

complete response rate (%CR+%CRu)

Key secondary outcomes

overall survival, progression-free survival, CR duration, toxicity

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

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

15 years-old <=

Age-upper limit

70 years-old >

Gender

Male and Female

Key inclusion criteria

(1) Biopsy-proven Hodgkin lymphoma
(2) Clinical stage IB, IIB, III, IV or bulky IA, IIA
(3) PS 0-3 (ECOG)
(3) No severe organ dysfunction
(4) Age: 15<=, < 70
(5) Previously untreated
(6) With evaluable lesions
(7) Written informed consent

Key exclusion criteria

1. insulin dependent diabetes mellitus
2. severe comorbidity (e.g. severe infectious disease, heart failure, pulmonary disease, hepatic failure, liver cirrhosis, acute/chronic hepatitis, renal failure, active tuberculosis)
3. other active neoplasms except insitu carcinoma of uterus and basal cell carcinoma of skin)
4. psychological disease
5. severe cardiac disease that may deteriorate by doxorubicin. Past history of myocardial infarction, heart failure, renal failure. Past history of angina pectoris 3 months before entry.
6. Pregnant or feeding women
7. CNS involvement by lymphoma
8. Positive for HBs-Ag, HCV-Ab, HIV or HTLV-1

Target sample size

108

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name Yasuo Morishima, MD, PhD

Organization

Aichi Cancer Center Hospitai

Division name

Department of Hematology and Cell Therapy

Zip code

Address

Kanokoden 1-1, Chikusaku, Nagoya, Aichi 464-8681, Japan

TEL

Email

Public contact

Name of contact person

1st name

Middle name

Last name Michinori Ogura, MD, PhD

Organization

JCOG9705 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

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2005 Year 08 Month 18 Day

Related information

URL releasing protocol

Publication of results

Published

Result

URL related to results and publications

http://www.ncbi.nlm.nih.gov/pubmed/22712838

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

Terminated

Date of protocol fixation

1997 Year 11 Month 25 Day

Date of IRB

Anticipated trial start date

1998 Year 02 Month 01 Day

Last follow-up date

2005 Year 12 Month 01 Day

Date of closure to data entry

2005 Year 12 Month 01 Day

Date trial data considered complete

2005 Year 12 Month 01 Day

Date analysis concluded

2005 Year 12 Month 01 Day

Other

Other related information

Management information

Registered date

2005 Year 08 Month 18 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=R000000113

1st name
Middle name
Last name	Yasuo Morishima, MD, PhD