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

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)

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)

Scientific Title:Acronym

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)

Region

Japan


Condition

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

NO


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

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

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

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 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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name