UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000013414