JCOG0905: A Phase III Study Comparing Methotrexate, Adrimycin and Cisplatin (MAP) with MAP + Ifosfamide (MAP + IF) for the Treatment of Osteosarcoma (OS-MAP + IF-P3)

未提供0 个研究点目标入组 250 人开始时间: 2010年4月14日最近更新: 2025年2月20日

试验速览

暂无简介。

•Histologically and Radiologically confirmed high grade osteosarcoma.
•Ten or more slides of biopsy specimen available for central pathological review.
•Tumor located in upper/lower extremity/sternum/rib.
•Resectable tumor.
•Stage IIA, IIB, or III of 6th Edition TNM-UICC classification.
•No previous history of osteosarcoma.
•No previous history of chemotherapy and radiotherapy for any cancers.
•No definite findings of familial tumors.
•Aged 50 years old or less.
•Performance Status (ECOG): 0 or
•Sufficient organ functions.
•Written informed consent.

•Uncontrollable diabetes mellitus.
•Uncontrollable hypertension.
•History of myocardial infarction or attack of unstable angina pectoris.
•Using artificial cardiac pacemaker.
•Active infection.
•Fever over 38 degrees centigrade.
•Simultaneous or metachronous (within the past 5 years) double cancers.
•Women during pregnancy or breast-feeding.
•Women within 28 days after delivery or women 29 days or more after delivery without uterine subinvolution confirmed by an obstetrician.
•Psychiatric disease or symptom.
•Systemic steroids medication.
•Positive for HBs antigen, HBc antibody, or HBs antibody.

Disease free survival

未报告次要终点

发起方

未提供