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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000008634
Receipt No. R000010144
Scientific Title Evaluation of the efficacy of XELOX for Japanese patients with completely resected stage II / stage III rectal cancer
Date of disclosure of the study information 2012/08/06
Last modified on 2020/02/11

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Basic information
Public title Evaluation of the efficacy of XELOX for Japanese patients with completely resected stage II / stage III rectal cancer
Acronym Evaluation of the efficacy of XELOX for Japanese patients with completely resected stage II / stage III rectal cancer
Scientific Title Evaluation of the efficacy of XELOX for Japanese patients with completely resected stage II / stage III rectal cancer
Scientific Title:Acronym Evaluation of the efficacy of XELOX for Japanese patients with completely resected stage II / stage III rectal cancer
Region
Japan

Condition
Condition Rectal cancer
Classification by specialty
Surgery in general Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of XELOX for Japanese patients with completely resected stage II / stage III rectal cancer
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes 3-year disease free survival rate
Key secondary outcomes 5-year overall survival rate
safety, completion rate, relative dose intensity

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 Adjuvant chemotherapy with oxaliplatin plus capecitabine
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) Pathologically or cytologically confirmed colorectal cancer
2) High-risk stage II or stage III rectal cancer
3) Curability A surgery (no residual tumor visible to macroscopically and/or microscopically)
4) Age >= 20 years
5) ECOG performance status of 0-1
6) Patient of possible oral ingestion
7) No prior chemotherapy or radiotherapy
8) Able to start within 8 weeks after surgery
9) Adequate organ function
10) Written informed consent
Key exclusion criteria 1) Postoperative complications
2) Active double cancer
3) Severe neuropathy or sensory dysfunction.
4) Women who are pregnant or breast-feeding
5) Serious drug allergy
6) Clinically significant infectious disease
7) Clinically significant psychological disease
8) Patient who has any of the following complications
i) Uncontrolled diabetes mellitus
ii) Uncontrolled hypertension
iii) Interstitial pneumonitis,lung fibrosis
iv) Ileus or bowel obstruction
v) Clinically significant heart disease
9) Other reasons for being unfit for the study as determined by the attending physician
Target sample size 95

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masataka Ikeda
Organization National Hospital Organization Osaka National Hospital
Division name Department of Surgery
Zip code
Address 2-1-14,Houenzaka,Chuou-ku,Osaka, 540-0006
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tsunekazu Mizushima
Organization Osaka University Graduate School of Medicine
Division name Department of Surgery
Zip code
Address 2-2 Yamadaoka, Suita, Osaka 565-0871,Japan
TEL 06-6879-3251
Homepage URL
Email tmizushima@gesurg.med.osaka-u.ac.jp

Sponsor
Institute Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
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

Other administrative information
Date of disclosure of the study information
2012 Year 08 Month 06 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6751668/pdf/12885_2019_Article_6122.pdf
Number of participants that the trial has enrolled 107
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 Main results already published
Date of protocol fixation
2012 Year 07 Month 12 Day
Date of IRB
2012 Year 07 Month 12 Day
Anticipated trial start date
2012 Year 08 Month 06 Day
Last follow-up date
2019 Year 02 Month 25 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6751668/pdf/12885_2019_Article_6122.pdf

Management information
Registered date
2012 Year 08 Month 06 Day
Last modified on
2020 Year 02 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010144

Research Plan
Registered date File name
2016/07/06 直腸癌治癒切除例に対する術後補助化学療法としてのXELOX療法の有効性確認試験《XELOX-RC》.zip

Research case data specifications
Registered date File name

Research case data
Registered date File name


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