JCOG0905:A Phase III Study Comparing Methotrexate, Adrimycin and Cisplatin (MAP) with MAP + Ifosfamide (MAP + IF) for the Treatment of Osteosarcoma
- Conditions
- High grade osteosarcoma, TNM stage II-III
- Registration Number
- JPRN-jRCTs031180126
- Lead Sponsor
- HIRAGA Hiroaki
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 250
1) Histologically and Radiologically confirmed high grade osteosarcoma.
2) Ten or more slides of biopsy specimen available for central pathological review.
3) Tumor located in upper/lower extremity/sternum/rib.
4) Resectable tumor.
5) Stage IIA, IIB, or III of 6th Edition TNM-UICC classification.
6) No previous history of osteosarcoma.
7) No previous history of chemotherapy and radiotherapy for any cancers.
8) No definite findings of familial tumors.
9) Aged 50 years old or less.
10) Performance Status (ECOG): 0 or 1.
11) Sufficient organ functions.
12) Written informed consent.
1) Uncontrollable diabetes mellitus.
2) Uncontrollable hypertension.
3) History of myocardial infarction or attack of unstable angina pectoris.
4) Using artificial cardiac pacemaker.
5) Active infection.
6) Fever over 38 degrees centigrade.
7) Simultaneous or metachronous (within the past 5 years) double cancers.
8) Women during pregnancy or breast-feeding.
9) Women within 28 days after delivery or women 29 days or more after delivery without uterine subinvolution confirmed by an obstetrician.
10) Psychiatric disease or symptom.
11) Systemic steroids medication.
12) Positive for HBs antigen, HBc antibody, or HBs antibody.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease free survival
- Secondary Outcome Measures
Name Time Method Overall survival, Relapse free survival, Proportion of disease progression until surgery, Adverse events, Limb function