UMIN ID: C000000068
Registered date:18/08/2005
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)
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | previouly untreated advanced stage Hodgkin lymphoma (stage IB, IIB, III, IV, or bulky) |
| Date of first enrollment | 1998/02/01 |
| Target sample size | 108 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | polychemotherapy, raiotheraoy |
Outcome(s)
| Primary Outcome | complete response rate (%CR+%CRu) |
|---|---|
| Secondary Outcome | overall survival, progression-free survival, CR duration, toxicity |
Key inclusion & exclusion criteria
| Age minimum | 15years-old |
|---|---|
| Age maximum | 70years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude 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 |
Related Information
| Primary Sponsor | Japan Clinical Oncology Group(JCOG) |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Ministry of Health, Labour and Welfare |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Michinori Ogura, MD, PhD |
| Address | Myokencho 2-9, Showaku, Nagoya, Aichi 466-8650, Japan Japan |
| Telephone | |
| JCOG_sir@ml.jcog.jp | |
| Affiliation | JCOG9705 Coordinating Office Department of Hematology, Nagoya Daini Red Cross Hospital |
| scientific contact | |
| Name | Yasuo Morishima, MD, PhD |
| Address | Kanokoden 1-1, Chikusaku, Nagoya, Aichi 464-8681, Japan Japan |
| Telephone | |
| Affiliation | Aichi Cancer Center Hospitai Department of Hematology and Cell Therapy |