UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005808 |
|---|---|
| Receipt number | R000006795 |
| Scientific Title | Fluorouracil/leucovorin, irinotecan and oxaliplatin (FOLFIRINOX): a phase II study in non-resectable pancreatic cancer patients. |
| Date of disclosure of the study information | 2011/06/20 |
| Last modified on | 2011/06/20 10:18:36 |
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Basic information
Public title
Fluorouracil/leucovorin, irinotecan and oxaliplatin (FOLFIRINOX): a phase II study in non-resectable pancreatic cancer patients.
Acronym
(FOLFIRINOX): a phase II
Scientific Title
Fluorouracil/leucovorin, irinotecan and oxaliplatin (FOLFIRINOX): a phase II study in non-resectable pancreatic cancer patients.
Scientific Title:Acronym
(FOLFIRINOX): a phase II
Region
| Japan |
Condition
Condition
Pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hematology and clinical oncology | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the safety and efficacy of FOLFIRINOX for Japanese patients with non-resectable pancreatic cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Safety and feasibility in FOLFIRINOX.
Key secondary outcomes
Response rate, survival rate, progression-free survival rate,and toxicity.
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
Oxaliplatin 85mg/m2 x 2hours, Leucovorin 400 mg/m2 x 2hours, Irinotecan 125 mg/m2 x 1.5hours, 5-FU 400mg/m2 x bolus, and 5-FU 2400 mg/m2 x 46hours (q2wks).
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
| 18 | years-old | <= |
Age-upper limit
| 76 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Histologically and cytologically
confirmed, measurable metastatic
pancreatic adenocarcinoma.
2.18 years of age or older.
3.ECOG performance status score of
0 or 1.
4.Granulocyto count >1500
5.Platelet count > 100,000
6.bilirubin < 1.5 times the upper limit
of the normal range.
7. Normal renal function
Key exclusion criteria
1.Age of 76 years or older.
2.Endocrine or acinar pancreatic
carcinoma.
3.Brain metastases.
4.Another major cancer.
5.Active infection.
6.Chronic diarrhea.
7.Cardiac disease
8.Pregnancy or breast-feeding
9.In the UGT1A1 allele,
UGT1A1 (*)28/(*)28 genotype
UGT1A1 (*)28/(*)6 genotype
UGT1A1 (*)6/(*)6 genotype
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Itaru Endo |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, Japan
TEL
045-787-2800
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasushi Ichikawa |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Clinical Oncology
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, Japan
TEL
045-787-2800
Homepage URL
Sponsor or person
Institute
Yokohama City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Local Government
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
横浜市立大学附属病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 06 | Month | 20 | 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
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 06 | Month | 20 | Day |
Last modified on
| 2011 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006795
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
