Unique ID issued by UMIN | UMIN000003197 |
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Receipt number | R000003846 |
Scientific Title | 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) |
Date of disclosure of the study information | 2010/02/16 |
Last modified on | 2021/01/06 13:41:38 |
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)
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)
Japan |
High grade osteosarcoma, TNM stage II-III
Pediatrics | Orthopedics |
Malignancy
NO
To evaluate the superiority of MAP-IF over MAP for standard responders after neoadjuvant chemotherapy with MAP and tumor resection in nonmetastatic resectable high grade osteosarcoma.
Efficacy
Confirmatory
Phase III
Disease free survival
Overall survival, Relapse free survival, Proportion of disease progression until surgery, Adverse events, Limb function
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
YES
Institution is considered as adjustment factor in dynamic allocation.
NO
Central registration
3
Treatment
Medicine |
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.
Not applicable |
50 | years-old | >= |
Male and Female
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.
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.
250
1st name | |
Middle name | |
Last name | Hiroaki Hiraga |
National Hospital Organization Hokkaido Cancer Center
Division of Orthopaedics
3-54, Kikusui 4-jo 2-chome, Shiroishi-ku, Sapporo, Hokkaido, 003-0804, Japan
011-811-9111(521)
hhiraga@sap-cc.go.jp
1st name | |
Middle name | |
Last name | Hiroaki Hiraga |
JCOG0905 Coordinating Office
Division of Orthopaedics, National Hospital Organization Hokkaido Cancer Center
3-54, Kikusui 4-jo 2-chome, Shiroishi-ku, Sapporo, Hokkaido, 003-0804, Japan
011-811-9111(521)
http://www.jcog.jp/
JCOG_sir@ml.jcog.jp
Japan Clinical Oncology Group(JCOG)
Japan Agency for Medical Research and Development
Other
Japan
NO
国立病院機構北海道がんセンター(北海道)
札幌医科大学(北海道)
東北大学病院(宮城県)
千葉県がんセンター(千葉県)
国立がん研究センター中央病院(東京都)
日本大学医学部板橋病院(東京都)
杏林大学医学部(東京都)
がん・感染症センター都立駒込病院(東京都)
慶應義塾大学病院(東京都)
東京医科歯科大学(東京都)
がん研究会有明病院(東京都)
順天堂大学医学部附属順天堂医院(東京都)
帝京大学医学部(東京都)
横浜市立大学附属病院(神奈川県)
神奈川県立病院機構神奈川県立がんセンター(神奈川県)
新潟県立がんセンター新潟病院(新潟県)
新潟大学医歯学総合病院(新潟県)
岐阜大学医学部(岐阜県)
静岡県立静岡がんセンター(静岡県)
愛知県がんセンター中央病院(愛知県)
名古屋大学医学部(愛知県)
三重大学医学部(三重県)
京都大学医学部附属病院(京都府)
大阪大学医学部(大阪府)
大阪府立病院機構大阪府立成人病センター(大阪府)
神戸大学医学部(兵庫県)
岡山大学病院(岡山県)
広島大学病院(広島県)
香川大学医学部(香川県)
国立病院機構九州がんセンター(福岡県)
久留米大学医学部(福岡県)
九州大学病院(福岡県)
大分大学医学部附属病院(大分県)
2010 | Year | 02 | Month | 16 | Day |
Unpublished
No longer recruiting
2010 | Year | 01 | Month | 12 | Day |
2010 | Year | 02 | Month | 12 | Day |
2010 | Year | 02 | Month | 16 | Day |
2029 | Year | 02 | Month | 16 | Day |
2010 | Year | 02 | Month | 16 | Day |
2021 | Year | 01 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003846
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