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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000002797
Receipt No. 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

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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
Email 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
Email thorimat@kuhp.kyoto-u.ac.jp

Sponsor
Institute Graduate School of Medicine, Kyoto University
Institute
Department

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
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 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&#8211;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&#8211;10.2) and 17.3 months (95% CI, 11.7&#8211;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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003397

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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