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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | C000000092 |
Receipt No. | 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 |
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)
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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)
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Region |
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Condition | ||
Condition | previouly untreated advanced stage Hodgkin lymphoma (stage II, III, IVy) | |
Classification by specialty |
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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
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 108 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 | |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |