NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
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) studiedpreviouly untreated advanced stage Hodgkin lymphoma (stage IB, IIB, III, IV, or bulky)
Date of first enrollment1998/02/01
Target sample size108
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)polychemotherapy, raiotheraoy

Outcome(s)

Primary Outcomecomplete response rate (%CR+%CRu)
Secondary Outcomeoverall survival, progression-free survival, CR duration, toxicity

Key inclusion & exclusion criteria

Age minimum15years-old
Age maximum70years-old
GenderMale and Female
Include criteria
Exclude criteria1. 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

Contact

public contact
Name Michinori Ogura, MD, PhD
Address Myokencho 2-9, Showaku, Nagoya, Aichi 466-8650, Japan Japan
Telephone
E-mail 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
E-mail
Affiliation Aichi Cancer Center Hospitai Department of Hematology and Cell Therapy