UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011459 |
|---|---|
| Receipt number | 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 16:12:13 |
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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
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
mnakan@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Department of Surgery
Division of Digestive Surgery
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
Kyoto Prefectural University of Medicine
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
Tel
075-251-5527
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013414
