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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN C000000096
Receipt No. R000000144
Scientific Title Neoadjuvant and adjuvant chemotherapy with ifosfamide and adriamycin for adult high-grade soft tissue sarcomas in the extremities (JCOG0304, Neoadjuvant and adjuvant chemotherapy with IFO/ADM phase II)
Date of disclosure of the study information 2005/08/30
Last modified on 2015/12/07

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Basic information
Public title Neoadjuvant and adjuvant chemotherapy with ifosfamide and adriamycin for adult high-grade soft tissue sarcomas in the extremities (JCOG0304, Neoadjuvant and adjuvant chemotherapy with IFO/ADM phase II)

Acronym Neoadjuvant and adjuvant chemotherapy with ifosfamide and adriamycin for adult high-grade soft tissue sarcomas in the extremities (JCOG0304, Neoadjuvant and adjuvant chemotherapy with IFO/ADM phase II)
Scientific Title Neoadjuvant and adjuvant chemotherapy with ifosfamide and adriamycin for adult high-grade soft tissue sarcomas in the extremities (JCOG0304, Neoadjuvant and adjuvant chemotherapy with IFO/ADM phase II)

Scientific Title:Acronym Neoadjuvant and adjuvant chemotherapy with ifosfamide and adriamycin for adult high-grade soft tissue sarcomas in the extremities (JCOG0304, Neoadjuvant and adjuvant chemotherapy with IFO/ADM phase II)
Region
Japan

Condition
Condition soft tissue sarcoma
Classification by specialty
Orthopedics
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and feasibility of neoadjuvant and adjuvant chemotherapy using adriamycin and ifosfamide on the patients with AJCC stage III soft tissue sarcomas in the extremities.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes response rate
Key secondary outcomes 2-year progression free survival, time to progression, overall survival, adverse effect, post-operative morbidity

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 Neoadjuvant and adjuvant chemotherapy
Interventions/Control_2
Interventions/Control_3
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
20 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria 1) A histological diagnosis of NRC-STS as malignant fibrous histiocytoma, fibrosarcoma, leiomyosarcoma, synovial sarcoma, liposarcoma, pleomorphic rhabdomyosarcoma, or undifferentiated sarcoma (WHO classification) using open biopsy specimen
2) FNCLCC histological grading system: grade 2 or 3 in the open biopsy specimen
3) 10 or more unstained tumor tissue slides are available
4) AJCC stage: stage III (T2bN0M0)
5) localized tumor in the extremities
6) measurable lesion on MRI axial section
7) operable tumor
8) no history of soft tissue sarcoma
9) no history of treatment for NRC-STS, chemotherapy nor radiation therapy for any cancer
10) age >20 and <65
11) an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
12) sufficient organ function within 14 days of entry
13) no blood transfusion within 14 days of entry
14) written informed consent
Key exclusion criteria 1) Poorly controlled diabetes mellitus
2) poorly controlled hypertension
3) history of myocardial infarction or angina
4) cardiac pacemaker
5) severe urinary dysfunction
6) infectious disease which requires treatment
7) mental disease or mental symptoms which would affect the patient's decision to participate
8) women in pregnant, possibly pregnant or breast feeding
9) active double cancer
10) continuous systemic medication of steroids
Target sample size 75

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yukihide Iwamoto, MD, PhD
Organization Graduate School of Medical Sciences, Kyushu University
Division name Department of Orthopaedic Surgery
Zip code
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, JAPAN
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kazuhiro Tanaka, MD, PhD
Organization JCOG0304 Coordinating Office
Division name Department of Orthopaedic Surgery, Kyushu University Hospital
Zip code
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, JAPAN
TEL
Homepage URL http://www.jcog.jp/
Email JCOG_sir@ml.jcog.jp

Sponsor
Institute Japan Clinical Oncology Group(JCOG)
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
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)
慶應義塾大学病院(東京都)
がん研究会有明病院(東京都)
帝京大学医学部(東京都)
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)
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)
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)
岡山大学医学部・歯学部附属病院(岡山県)
国立病院機構九州がんセンター(福岡県)

Other administrative information
Date of disclosure of the study information
2005 Year 08 Month 30 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/25838293
Number of participants that the trial has enrolled
Results
See the datails via "URL releasing results" above.
Also the details can be seen in the JCOG website: 
http://www.jcog.jp/en/trials/index.html
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 Main results already published
Date of protocol fixation
2004 Year 03 Month 11 Day
Date of IRB
Anticipated trial start date
2004 Year 03 Month 01 Day
Last follow-up date
2010 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2005 Year 08 Month 30 Day
Last modified on
2015 Year 12 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000144

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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