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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001094
Receipt No. R000001324
Scientific Title Phase II study of caffeine combined chemotherapy in patients with high- grade bone and soft tissue tumor
Date of disclosure of the study information 2008/03/25
Last modified on 2014/10/08

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Basic information
Public title Phase II study of caffeine combined chemotherapy in patients with high- grade bone and soft tissue tumor
Acronym Caffeine combined chemotherapy for high- grade bone and soft tissue tumor pII
Scientific Title Phase II study of caffeine combined chemotherapy in patients with high- grade bone and soft tissue tumor
Scientific Title:Acronym Caffeine combined chemotherapy for high- grade bone and soft tissue tumor pII
Region
Japan

Condition
Condition High-grade bone and soft tissue tumor
Classification by specialty
Orthopedics
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To determine the safety and efficacy of caffeine combined chemotherapy in patients with high-grade bone and soft tissue tumor
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes The response rate of preoperative caffeine combined chemotherapy
Key secondary outcomes 2-year progression free survival, event-free survival, overall survival, incidence of adverse event

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
Interventions/Control_1 Caffeine combined chemotherapy in which cisplatin over 4 hours followed by caffeine over 24 hours on days 1-3, to be repeaed every 3 weeks
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
5 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria 1. bone tumor (osteosarcoma, malignant fibrous histiocytoma), soft tissue tumor (non-round cell soft tissue tumor: malignant fibrous histiocytoma, fibrosarcoma, leiomyosarcoma, synovial sarcoma, liposarcoma, pleomorphic rhabdomyosarcoma, undifferentiated sarcoma)
2. Grade 2-3 high grade tumor judged by FNCLCC(French Federation of Cancer Center) system
3. extremity, trunk, retroperitoneum
4. calculatable tumor size by MRI
5. resectable
6. no history of malignant bone and soft tissue tumor
7. no prior chemotherapy or radiation for malignant tumor
8. 0-1 in ECOG PS
confirming the following laboratory results
(1) WBC>=3000/mm3, Hb>=8g/dL,
P1t>=100000/mm3
(2) liver renzyme: serum T-bil<=1.5mg/dL,
GOT, GPT<=2 X normal value
(3) serum creatinine<=1.5 mg/dL,
Ccr>=60 mL/min
(4) normal findings of ECG and cardiac
ultrasound
(5) blood gas analysis: PaO2>=70 mmHg,
(PaCO2<=50 Torr)
9. no evidence of psycosis, sever diabetes mellitus, uncontrolled hypertension
10. written informed consent from patients or legal guardian (20 years and under)
Key exclusion criteria 1.sever drug allergy
2.uncontrolled diabetes mellitus
3.uncontrolled hypertension
4.women during pregnancy
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiyoruki Tsuchiya
Organization Kanazawa University
Division name Department of orthopaedic surgery, Graduate school of medical science
Zip code
Address 13-1 Takara-machi, Kanazawa 920-8640, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Toshiharu Shirai
Organization Coordinate Office
Division name Department of orthopaedic surgery, Graduate school of medical science, Kanazawa Univesity
Zip code
Address 13-1 Takara-machi, Kanazawa 920-8640, Japan
TEL 076-265-2374
Homepage URL
Email

Sponsor
Institute Group for "Caffeine combined chemotherapy in patients with high-grade bone and soft tissue tumor"
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

Other administrative information
Date of disclosure of the study information
2008 Year 03 Month 25 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 Completed
Date of protocol fixation
2008 Year 03 Month 15 Day
Date of IRB
Anticipated trial start date
2008 Year 03 Month 01 Day
Last follow-up date
2011 Year 03 Month 01 Day
Date of closure to data entry
2014 Year 10 Month 17 Day
Date trial data considered complete
2014 Year 10 Month 17 Day
Date analysis concluded
2014 Year 10 Month 17 Day

Other
Other related information

Management information
Registered date
2008 Year 03 Month 24 Day
Last modified on
2014 Year 10 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001324

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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