UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035475 |
|---|---|
| Receipt number | R000040380 |
| Scientific Title | Analisis of symptom monitoring using Xeloda application system during adjuvant chemoterapy for post-operatived colon cancer |
| Date of disclosure of the study information | 2019/01/07 |
| Last modified on | 2022/09/20 15:01:36 |
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Basic information
Public title
Analisis of symptom monitoring using Xeloda application system during adjuvant chemoterapy for post-operatived colon cancer
Acronym
Analisis of symptom monitoring using Xeloda application system during adjuvant chemoterapy for post-operatived colon cancer
Scientific Title
Analisis of symptom monitoring using Xeloda application system during adjuvant chemoterapy for post-operatived colon cancer
Scientific Title:Acronym
Analisis of symptom monitoring using Xeloda application system during adjuvant chemoterapy for post-operatived colon cancer
Region
| Japan |
Condition
Condition
Post-operatived colon cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We evaluate emotional disorder, adverse event, dose intensity for cases with postoperative adjuvant chemotherapy for colon cancer using ICT (Information and Communication Technology) tool.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Emotional disorder evaluation
Key secondary outcomes
Adverse event
Dose intensity
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Intervation design
Xeloda application using group: 10 cases
Chemotherapy with Capecitabine(1000mg/m2/day 1-14days), Oxaliplatin(130mg/m2/day day1),every triweekly
Intervation period: 6 months
Interventions/Control_2
Intervation design
Xeloda application using group: 10 cases
Chemotherapy with Capecitabine(1000mg/m2/day 1-14days), Oxaliplatin(130mg/m2/day day1),every triweekly
Intervation period: 6 months
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Case requiring postoperative adjuvant chemotherapy after resection of colon cancer
2. Performance Status (ECOG) 0-1
3. Sufficient oral intake
4. Adequate organ functions:
WBC >=3500/mm3 and <=12000/mm3,
neutrophils >=2000/mm3,
platelets >=100,000/mm3,
hemoglobin >=9.0g/dL,
total bilirubin <=1.5mg/dL,
AST(GOT)/ALT(GPT) within twice the normal upper limits
Key exclusion criteria
1. patient who has drug allergy as past history
2. patient who needs flucytosine, phenytoin, and Warfarin
3. patient who has active infectious disease with fever over 38 degree
4. patient who has severe complication (interstitial pneumonia, DM, renal failure, liver failure under bad control)
5. watery diarrhea
6. Pleural effusion and acites
7. patient who has heart disease(CHF, old MI, IHD, arrhythmia, and a valvular disease of the heart)
8.Uncontrolable hypertention
9. patient who want to be pregnant and /or pregnant woman
10. man who want to have a child
11. patient who was judged to be unsuitable for this clinical trial
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yoshinori |
| Middle name | |
| Last name | Kikuchi |
Organization
Faculty of Medcine, Toho University
Division name
Division of Gastroenterology and hepatology
Zip code
143-0015
Address
Building 2 of Clinical Reaerach 310, 7-5-23, Omori-Nishi Ota-ku, Tokyo 143-8541, Japan
TEL
03-3762-4151
y-kikuchi@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshinori |
| Middle name | |
| Last name | Kikuchi |
Organization
Faculty of Medcine, Toho University
Division name
Division of Gastroenterology and hepatology
Zip code
143-0015
Address
Building 2 of Clinical Reaerach 310, 7-5-23, Omori-Nishi Ota-ku, Tokyo 143-8541, Japan
TEL
03-3762-4151
Homepage URL
y-kikuchi@med.toho-u.ac.jp
Sponsor or person
Institute
Division of Gastroenterology and hepatology, Department of Internal Medcine, Faculty of Medcine, Toho University
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
Toho University Omori Medical Center
Address
6-11-1, Omori-Nishi Ota-ku, Tokyo 143-8541, Japan
Tel
03-3762-4151
omori.rinri@ext.toho-u.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
東邦大学医療センター大森病院
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 01 | Month | 07 | 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
| 2019 | Year | 01 | Month | 07 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 07 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 07 | Day |
Last modified on
| 2022 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040380
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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