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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)

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)

HIRAGA Hiroaki

Hokkaido Cancer Center

4-2-3-54,Kikusui,Shiroishi-ku,Sapporo, Hokkaido,Japan

hhiraga@nho-hcc.jp

HIRAGA Hiroaki

Hokkaido Cancer Center

4-2-3-54,Kikusui,Shiroishi-ku,Sapporo, Hokkaido,Japan

+81-11-811-9111

hhiraga@nho-hcc.jp

Not Recruiting

Feb. 16, 2010

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

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.

Both

High grade osteosarcoma, TNM stage II-III

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 standard responders after neoadjuvant chemotherapy with MAP and tumor resection
G: MAP for good responders (residual viable tumor cells less than 10% in resected tumor specimen) after neoadjuvant chemotherapy with MAP and tumor resection.

Disease free survival

Overall survival, Relapse free survival, Proportion of disease progression until surgery, Adverse events, Limb function

+81-3-3542-2511

Dec. 20, 2018

No

none