UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008634 |
|---|---|
| Receipt number | 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 | 2021/05/25 15:58:27 |
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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
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
tmizushima@gesurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
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
Address
Tel
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
| 2021 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.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 | |
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| Registered date | File name |
