UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000883 |
|---|---|
| Receipt number | R000001066 |
| Scientific Title | Phase I Trial of Infusional Fluorouracil, Leucovorin, Oxaliplatin, and Irinotecan(FOLFOXIRI) for Metastatic or Reccurence Colorectal Cancer |
| Date of disclosure of the study information | 2007/11/08 |
| Last modified on | 2009/09/04 22:01:48 |
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Basic information
Public title
Phase I Trial of Infusional Fluorouracil, Leucovorin, Oxaliplatin, and Irinotecan(FOLFOXIRI) for Metastatic or Reccurence Colorectal Cancer
Acronym
FOLFOXIRI(P-I)
Scientific Title
Phase I Trial of Infusional Fluorouracil, Leucovorin, Oxaliplatin, and Irinotecan(FOLFOXIRI) for Metastatic or Reccurence Colorectal Cancer
Scientific Title:Acronym
FOLFOXIRI(P-I)
Region
| Japan |
Condition
Condition
Colorectal Cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Determining the maximum tolerable dose(MTD) and recomended dose(RD)
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Safety
Key secondary outcomes
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
5FU
Leucovorin
Irinotecan
Oxaliplatin
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Colorectal cancer histologically confirmed as adenocarcinoma
2. Unresectable metastatic or recurrence colorectal cancer
3. Interval of at least 3 weeks between last chemotherapy treatment and start of present chemotherapy regimen
4.
5. Age from 20 to 70 years
6. ECOG performance status of 0, 1
7. Without history of other active malignancy
8. Interval of at least 4 weeks between last operation and start of present chemotherapy regimen
9.
a) leukocyte count of at least 3500/mm3
b) neutrophils count of at least 1500/mm3
c)
d) platelet count of at least 100000/mm3
e) AST, ALT 5 x normal values or less
f) serum bilirubin less than 1.2mg/dL
g) serum creatinine of 1.5mg/dL or less
10. Written informed consent
Key exclusion criteria
1. Severe infection
2.
3. History of Irinotecan, and Oxaliplatin use
4. Severe complication
5.
6. Regular use of
7. History of thromboembolism
8. Unmanageable hyper tention
9. Active ulcer
10. Symptomatic brain metastasis
11.
12.
13.
14. History of radiotherapy
15. Massive pleural effusion required drainage
16. Persistent diarrhea
17.
18.
19. HBs antigen and HCV antigen positive
20. Pregnancy or the desire to preserve fecundity
21.
22. Psychological disease deemed to unacceptable for inclusion to the study
23.
24. Inadequate physical condition, as diagnosed by primary physician
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasutsuna Sasaki |
Organization
Conprehensive Cancer Center, Saitama Medical University International Medical Center
Division name
Department of Clinical Oncology
Zip code
Address
1397-1 Yamane Hidaka Saitama
TEL
042-984-4111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yu Sunakawa |
Organization
Conprehensive Cancer Center, Saitama Medical University International Medical Center
Division name
Department of Clinical Oncology
Zip code
Address
TEL
Homepage URL
yu_s@saitama-med.ac.jp
Sponsor or person
Institute
Department of Clinical Oncology, Conprehensive Cancer Center, Saitama Medical University International Medical Center
Institute
Department
Personal name
Funding Source
Organization
Department of Clinical Oncology, Conprehensive Cancer Center, Saitama Medical University International Medical Center
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
| 2007 | Year | 11 | Month | 08 | 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
| 2007 | Year | 09 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2009 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 11 | Month | 08 | Day |
Last modified on
| 2009 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001066
