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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000003197
Receipt No. 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 2016/05/02

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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 Open public recruiting
Date of protocol fixation
2010 Year 01 Month 12 Day
Date of IRB
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
2016 Year 05 Month 02 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
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