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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003197

Enrollment

250

Registered

2010-02-16

Start date

2010-02-16

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High grade osteosarcoma, TNM stage II-III

Interventions

A: MAP for standard responders (residual viable tumor cells more than 10% in resected tumor specimen) after neoadjuvant chemotherapy with MAP and tumor resection. B: MAP-IF for sta

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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 TNM-UICC classification. 6) No previous history of osteosarcoma. 7) No previous history of chemotherapy and radiotherapy. 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.

Exclusion criteria

Exclusion criteria: 1) Uncontrollable diabetes mellitus. 2) Uncontrollable hypertension. 3) History of myocardial infarction or attack of unstable angina pectoris. 4) Artificial pacemaker. 5) Active bacterial or fungous 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) Psychosis. 11) Systemic steroids medication. 12) Positive for HBs antigen, HBc antibody, or HBs antibody.

Design outcomes

Primary

Measure	Time frame
Disease free survival	—

Secondary

Measure	Time frame
Overall survival, Relapse free survival, Proportion of disease progression until surgery, Adverse events, Limb function	—

Countries

Japan

Contacts

Public ContactHiroaki Hiraga

JCOG0905 Coordinating Office Division of Orthopaedics, National Hospital Organization Hokkaido Cancer Center

JCOG_sir@ml.jcog.jp011-811-9111(521)

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026