MedPath

Randomized phase II/III study of adjuvant chemotherapy with Adriamycin+Ifosfamide vs Gemcitabine+Docetaxel for high-grade soft tissue sarcoma (JCOG1306, AI vs GD for STS RPII/III)

Phase 2
Conditions
soft tissue sarcoma
Registration Number
JPRN-UMIN000013175
Lead Sponsor
Japan Clinical Oncology Group (JCOG)
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up continuing
Sex
All
Target Recruitment
140
Inclusion Criteria

Not provided

Exclusion Criteria

1) Synchronous or metachronous (within 5 years) malignancies except for carcinoma in situ or intramucosal tumors curatively treated with local therapy 2) Active infection requiring systemic therapy 3) Body temperature >= 38 degrees Celsius 4) Women in pregnant, possibly pregnant or breast feeding 5) Psychiatric disease 6) Patients requiring systemic steroid medication 7) Unstable angina within 3 weeks, or with a history of myocardial infarction 8) Poorly controlled hypertension 9) Poorly controlled diabetes mellitus or routine administration of insulin 10) Positive HBs antigen

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath