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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)

Phase 2
Conditions
previouly untreated advanced stage Hodgkin lymphoma (stage IB, IIB, III, IV, or bulky)
Registration Number
JPRN-C000000068
Lead Sponsor
Japan Clinical Oncology Group(JCOG)
Brief Summary

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

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
108
Inclusion Criteria

Not provided

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
complete response rate (%CR+%CRu)
Secondary Outcome Measures
NameTimeMethod
overall survival, progression-free survival, CR duration, toxicity
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