UMIN-CTR Clinical Trial

Basic information
Public 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)
Acronym	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)
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)
Scientific Title:Acronym	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)
Region	Japan

Condition
Condition	High grade osteosarcoma, TNM stage II-III
Classification by specialty	Pediatrics Orthopedics
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	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.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase III

Assessment
Primary outcomes	Disease free survival
Key secondary outcomes	Overall survival, Relapse free survival, Proportion of disease progression until surgery, Adverse events, Limb function

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	A: MAP for standard responders (residual viable tumor cells more than 10% in resected tumor specimen) after neoadjuvant chemotherapy with MAP and tumor resection.
Interventions/Control_2	B: MAP-IF for standard responders after neoadjuvant chemotherapy with MAP and tumor resection
Interventions/Control_3	G: MAP for good responders (residual viable tumor cells less than 10% in resected tumor specimen) after neoadjuvant chemotherapy with MAP and tumor resection.
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	50 years-old >=
Gender	Male and Female
Key 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.
Key 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.
Target sample size	250

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hiroaki Hiraga
Organization	National Hospital Organization Hokkaido Cancer Center
Division name	Division of Orthopaedics
Zip code
Address	3-54, Kikusui 4-jo 2-chome, Shiroishi-ku, Sapporo, Hokkaido, 003-0804, Japan
TEL	011-811-9111(521)
Email	hhiraga@sap-cc.go.jp

Public contact
Name of contact person	1st name Middle name Last name Hiroaki Hiraga
Organization	JCOG0905 Coordinating Office
Division name	Division of Orthopaedics, National Hospital Organization Hokkaido Cancer Center
Zip code
Address	3-54, Kikusui 4-jo 2-chome, Shiroishi-ku, Sapporo, Hokkaido, 003-0804, Japan
TEL	011-811-9111(521)
Homepage URL	http://www.jcog.jp/
Email	JCOG_sir@ml.jcog.jp

Sponsor
Institute	Japan Clinical Oncology Group(JCOG)
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions

Institutions

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）

Other administrative information
Date of disclosure of the study information	2010 Year 02 Month 16 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2010 Year 01 Month 12 Day
Date of IRB	2010 Year 02 Month 12 Day
Anticipated trial start date	2010 Year 02 Month 16 Day
Last follow-up date	2029 Year 02 Month 16 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2010 Year 02 Month 16 Day
Last modified on	2021 Year 01 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003846