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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000883
Receipt No. 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

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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
Email

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
Email yu_s@saitama-med.ac.jp

Sponsor
Institute Department of Clinical Oncology, Conprehensive Cancer Center, Saitama Medical University International Medical Center
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001066

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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