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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011459
Receipt No. R000013414
Scientific Title Exploratory study to evaluate the recurrence prediction factor in patients with completely resected colorectal cancer which has adjuvant therapy of XELOX.(KPUM-DS-C03)
Date of disclosure of the study information 2013/08/12
Last modified on 2019/08/19

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Basic information
Public title Exploratory study to evaluate the recurrence prediction factor in patients with completely resected colorectal cancer which has adjuvant therapy of XELOX.(KPUM-DS-C03)
Acronym Exploratory study to evaluate the recurrence prediction factor in patients with completely resected colorectal cancer which has adjuvant therapy of XELOX.(KPUM-DS-C03)
Scientific Title Exploratory study to evaluate the recurrence prediction factor in patients with completely resected colorectal cancer which has adjuvant therapy of XELOX.(KPUM-DS-C03)
Scientific Title:Acronym Exploratory study to evaluate the recurrence prediction factor in patients with completely resected colorectal cancer which has adjuvant therapy of XELOX.(KPUM-DS-C03)
Region
Japan

Condition
Condition Colorectal Cancer
Classification by specialty
Surgery in general Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the correlation of a clinical response and a clinicopathologic factor and search for a recurrence prediction factor.
Basic objectives2 Others
Basic objectives -Others Searches of the recurrence prediction factor.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Correlation of a clinical response and a clinicopathologic factor.
Key secondary outcomes Correlation of Dose Intensity and Relapse Free Survival.
Safety

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. Histologically confirmed colorectal cancer
2. High risk stage II or stage III
3. Curability A surgery
4. Age >= 20 years
5. ECOG performance status of 0-1
6. Treatment plan of XElOX adjuvant therapy
7. Adequate organ function
8. Signed written informed consent
Key exclusion criteria 1. Prior oxaliplatin therapy
2. Prior chemotherapy or radiotherapy for colorectal cancer
3. Brain metastasis or active multiple malignancy
4. Peripheral nerve disorder
5. A history of severe drug allergy
6. Active infectious disease
7. Significant mental illness
8. Following complications
i) Uncontrolled diabetes
ii) Uncontrolled hypertension
iii) Interstitial pneumonia
iv) Iintestinal tract paralysis or ileus
v) Significant heart trouble
9. Inadequate for study enrollment by the physician
Target sample size 300

Research contact person
Name of lead principal investigator
1st name Masayoshi
Middle name
Last name Nakanishi
Organization Kyoto Prefectural University of Medicine
Division name Department of Surgery Division of Digestive Surgery
Zip code 602-8566
Address 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL 075-251-5527
Email mnakan@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name Masayoshi
Middle name
Last name Nakanishi
Organization Kyoto Prefectural University of Medicine
Division name Division of Digestive Surgery
Zip code 602-8566
Address 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL 075-251-5527
Homepage URL
Email mnakan@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine
Department of Surgery
Division of Digestive Surgery
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 Kyoto Prefectural University of Medicine
Address 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
Tel 075-251-5527
Email mnakan@koto.kpu-m.ac.jp

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 京都府立医科大学病院
京都第二赤十字病院
京都第一赤十字病院
大阪鉄道病院
松下記念病院
済生会滋賀県病院
明石市立市民病院
社会保険京都病院
社会保険神戸中央病院
京都府立医科大学付属北部医療センター
公立南丹病院
近江八幡市立総合医療センター
済生会京都府病院
綾部市立病院
市立奈良病院
市立福知山病院
愛生会山科病院
国立舞鶴医療センター
京都山城総合医療センター
西陣病院
京都きづ川病院
第二岡本総合病院
堀川病院
亀岡市立病院
北出病院
京都九条病院
洛西ニュータウン病院
舞鶴赤十字病院
六地蔵病院

Other administrative information
Date of disclosure of the study information
2013 Year 08 Month 12 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 251
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
2013 Year 07 Month 24 Day
Date of IRB
2013 Year 07 Month 26 Day
Anticipated trial start date
2013 Year 08 Month 12 Day
Last follow-up date
2019 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Clinical Response
Clinicopathologic Factor
Adverse Event

Management information
Registered date
2013 Year 08 Month 12 Day
Last modified on
2019 Year 08 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013414

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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