UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007856 |
|---|---|
| Receipt number | R000009256 |
| Scientific Title | Assessment of clinical availability for one-on-one phone support Program in capecitabine together with oxaliplatin (CapeOx) as adjuvant chemotherapy in patient with Stage III Colon Cancer; Multi-center Observation study. |
| Date of disclosure of the study information | 2012/05/01 |
| Last modified on | 2014/06/04 19:01:03 |
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Basic information
Public title
Assessment of clinical availability for one-on-one phone support Program in capecitabine together with oxaliplatin (CapeOx) as adjuvant chemotherapy in patient with Stage III Colon Cancer;
Multi-center Observation study.
Acronym
EXTENSION Study
Scientific Title
Assessment of clinical availability for one-on-one phone support Program in capecitabine together with oxaliplatin (CapeOx) as adjuvant chemotherapy in patient with Stage III Colon Cancer;
Multi-center Observation study.
Scientific Title:Acronym
EXTENSION Study
Region
| Japan |
Condition
Condition
StageIII colon cancer
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Hematology and clinical oncology |
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the clinical availability of one-on-one phone support Program for adverse event management in capecitabine together with oxaliplatin (CapeOx) as adjuvant chemotherapy in patient with Stage III Colon Cancer.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Hand-Foot Syndrome (> grade 3) events rate.
Key secondary outcomes
Completion rate.
Evaluation of QOL(Skin Toxicity - Related symptoms)
3-year Relapse-free survival.
Compliance.
Relative dose intensity.
Duration of a call.
Patient satisfaction for phone support Program.
Number of all outpatient visits.
Number of phone times for Unscheduled.
Number of phone times after the Fourth course.
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) Histological confirmation of colorectal cancer with curative resection
(2) Patients Who scheduled to receive capecitabine together with oxaliplatin (CapeOx) treatment.
(3) Written informed consent.
(4) 20 years old or more when received informed consent.
(5) Eastern Cooperative Oncology Group (ECOG) performance status (PS) : 0 - 1.
(6) Patients who received no previous chemotherapy or radiotherapy treatment.
(7)Patients with oral intake is possible
Key exclusion criteria
(1)Patient condition corresponds with section of contraindication or contraindication in combination for the administration of Capecitabine and Oxaliplatin.
(2)Not appropriate for the study at the physician's assessment.
Target sample size
55
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kimihiko Funahashi |
Organization
Toho University Omori Medical Center
Division name
Division of Gastroenterological Surgery
Zip code
Address
6-11-1 Ohmori-nishi Ohta Tokyo
TEL
03-3762-4151
jkoike18@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junichi Koike |
Organization
Toho University Omori Medical Center
Division name
Division of Gastroenterological Surgery
Zip code
Address
6-11-1 Ohmori-nishi Ohta Tokyo
TEL
03-3762-4151
Homepage URL
jkoike18@med.toho-u.ac.jp
Sponsor or person
Institute
Division of Gastroenterological Surgery, Toho University Omori Medical Center
Institute
Department
Personal name
Funding Source
Organization
Division of Gastroenterological Surgery, Toho University Omori Medical Center
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 | 05 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2011 | Year | 02 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 05 | 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
none
Management information
Registered date
| 2012 | Year | 04 | Month | 28 | Day |
Last modified on
| 2014 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009256
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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