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
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/
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
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
