UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004429 |
|---|---|
| Receipt number | R000005264 |
| Scientific Title | Observation study for availability of phone support service for management of Capecitabine in patients with Colorectal Cancer(XTRA study) |
| Date of disclosure of the study information | 2010/10/25 |
| Last modified on | 2013/06/27 15:22:47 |
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Basic information
Public title
Observation study for availability of phone support service for management of Capecitabine in patients with Colorectal Cancer(XTRA study)
Acronym
Observation study for availability of phone support service for management of Capecitabine in patients with Colorectal Cancer(XTRA study)
Scientific Title
Observation study for availability of phone support service for management of Capecitabine in patients with Colorectal Cancer(XTRA study)
Scientific Title:Acronym
Observation study for availability of phone support service for management of Capecitabine in patients with Colorectal Cancer(XTRA study)
Region
| Japan |
Condition
Condition
Colorectal Cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the availability of phone support service for management of Capecitabine in patients with Colorectal Cancer
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Safety(grade3 of Hand-Foot Syndrome)
Key secondary outcomes
Premature withdrawal rate
treatment interruption rates
Time to recovery of HFS after interruption
Mean cumulative dose
Mean treatment duration
Compliance
duration of phone call
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.Capecitabine in treatment
2.Written informed consents
3.Age:>20 years
4.ECOG-PS:0-2
Key exclusion criteria
1.Uncontrolled Diarrhea
2.Other conditions not suitable for this study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | michio nakamura |
Organization
Sapporo City General Hospital
Division name
Division of Gastrointestinal Oncology and Endoscopy
Zip code
Address
KITA-11 NISHI-13-1-1,CHUO-KU,SAPPORO ,060-8604 ,Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Sapporo City General Hospital
Division name
Division of Gastrointestinal Oncology and Endoscopy
Zip code
Address
KITA-11 NISHI-13-1-1,CHUO-KU,SAPPORO ,060-8604 ,Japan
TEL
Homepage URL
Sponsor or person
Institute
Sapporo City General Hospital
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
| 2010 | Year | 10 | Month | 25 | 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
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
| 2010 | Year | 06 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: Prospective observational study
Management information
Registered date
| 2010 | Year | 10 | Month | 21 | Day |
Last modified on
| 2013 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005264
