UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035475
Receipt No. 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 2019/01/07

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Last name of lead principal investigator
1st name
Middle name
Last name Yoshinori Kikuchi
Organization Faculty of Medcine, Toho University
Division name Division of Gastroenterology and hepatology
Zip code
Address Building 2 of Clinical Reaerach 310, 7-5-23, Omori-Nishi Ota-ku, Tokyo 143-8541, Japan
TEL 03-3762-4151
Email y-kikuchi@med.toho-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Yoshinori Kikuchi
Organization Faculty of Medcine, Toho University
Division name Division of Gastroenterology and hepatology
Zip code
Address Building 2 of Clinical Reaerach 310, 7-5-23, Omori-Nishi Ota-ku, Tokyo 143-8541, Japan
TEL 03-3762-4151
Homepage URL
Email y-kikuchi@med.toho-u.ac.jp

Sponsor
Institute Division of Gastroenterology and hepatology, Department of Internal Medcine, Faculty of Medcine, Toho University
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 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 Open public recruiting
Date of protocol fixation
2019 Year 01 Month 07 Day
Date of IRB
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
2020 Year 12 Month 31 Day
Date trial data considered complete
2020 Year 12 Month 31 Day
Date analysis concluded
2020 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2019 Year 01 Month 07 Day
Last modified on
2019 Year 01 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040380

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.