UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002797 |
|---|---|
| Receipt number | R000003397 |
| Scientific Title | Phase II study of the combination of Oxaliplatin and 5FU(mFOLFOX6) in patients with unresectable advanced/recurrent small intestinal cancer |
| Date of disclosure of the study information | 2009/11/24 |
| Last modified on | 2014/05/25 08:28:02 |
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Basic information
Public title
Phase II study of the combination of Oxaliplatin and 5FU(mFOLFOX6) in patients with unresectable advanced/recurrent small intestinal cancer
Acronym
Phase II study of mFOLFOX6 in patients with unresectable advanced/recurrent small intestinal cancer
Scientific Title
Phase II study of the combination of Oxaliplatin and 5FU(mFOLFOX6) in patients with unresectable advanced/recurrent small intestinal cancer
Scientific Title:Acronym
Phase II study of mFOLFOX6 in patients with unresectable advanced/recurrent small intestinal cancer
Region
| Japan |
Condition
Condition
unresectable advanced/recurrent small intestinal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate clinical efficacy and safety of the mFOLFOX6 in patients with unresectable advanced/recurrent small intestinal cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Progression-Free rate
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
mFOLFOX6
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Histologically confirmed small intestinal cancer.
2.Unresectable/reccurent small intestinal cancer
3.PS is 0, 1 or 2
4.Over 20 years and under 80 years of age
5.Sufficient oral intake survival period
6.Adequate organ function
7.Wrtten informed consent
Key exclusion criteria
1. Active other malignancies
2. Without assessable lesions
3. Active infectious disease
4. Peripheral neuropathy
5. Active Hemorrhage/bleeding
6. Uncontrollable watery diarrhea
7. Brain metastasis
8. Transfusion or blood product or growth factor such as G-CSF less than 7 days prior to entry
9. HBV carrier
10. Severe complications(ileus, interstitial pneumonitis, pulmonary fibrosis, uncontrollable diabetes mellitus, heart failure)
11. Pregnant or lactating woman
12. Severe psychological disease
13. Systemic steroid administration
14. Phenytoin, Warfarin potassium, or flucytosin administration
15. Not appropriate for the study at the physician's assessmnt
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Manabu Muto |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
Kawahara-cho, 54, Shogoin, Sakyo-ku, Kyoto
TEL
075-751-4592
mmuto@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahiro Horimatsu |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
54 Kawahara-cho Shogoin Sakyo-ku Kyoto
TEL
075-751-3518
Homepage URL
thorimat@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Kyoto University
Institute
Department
Personal name
Funding Source
Organization
none
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
愛知がんセンター（愛知県）大阪赤十字病院（大阪府）京都医療センター（京都府）京都桂病院（京都府）京都大学医学部附属病院（京都府）北野病院（大阪府）倉敷中央病院（岡山県）神戸中央市民病院（兵庫県）島根大学（島根県）天理よろず相談所病院（奈良県）富山大学病院（富山県） 筑波大学附属病院（茨城県）静岡県立静岡がんセンター(静岡県) 石川県立中央病院(石川県) 九州大学医学部付属病院(福岡県) 宮城県立がんセンター（宮城県） 宮崎大学医学部（宮崎県） 神奈川県立がんセンター(神奈川県) 大分大学医学部（大分県） 杏林大学（東京都） 近畿大学（大阪府） 埼玉県立がんセンタ－（埼玉県） 札幌医科大学（北海道） 静岡県立総合病院（静岡県）兵庫県立がんセンター（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 11 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Between April 2010 and November 2012, 24 patients were enrolled from 12 institutions. Median age: 63 years old (range, 31–79); male/female ratio: 18/6; PS 0: 17 (71%); PS 1: 7 (29%); locally advanced/metastatic disease: 2/22; primary tumor site: duodenum (58%) and jejunum (42%). The median follow-up time was 14.7 months (3.7-40.3). The 1-year PFS was 23.3%. The ORR was 45% (9/20). The median PFS and OS were 5.9 months (95% CI, 3.0–10.2) and 17.3 months (95% CI, 11.7–19.0), respectively. The common grade 3 or 4 toxicities were neutropenia (38%), anemia/peripheral neuropathy (25%), stricture (17%), fatigue/anorexia/bilirubin increase (8%), and diarrhea (4%). There were no treatment-related deaths.
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
Main results already published
Date of protocol fixation
| 2009 | Year | 10 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 11 | Month | 26 | Day |
Date of closure to data entry
| 2013 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 01 | Month | 15 | Day |
Date analysis concluded
| 2014 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 11 | Month | 24 | Day |
Last modified on
| 2014 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003397
