UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001094 |
|---|---|
| Receipt number | 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 10:19:13 |
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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
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
Sponsor or person
Institute
Group for "Caffeine combined chemotherapy in patients with high-grade bone and soft tissue tumor"
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001324
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| Registered date | File name |
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