UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016446 |
|---|---|
| Receipt number | R000019102 |
| Scientific Title | XELODA Special Drug Use Surveillance, XELOX as adjuvant chemotherapy for colon cancer |
| Date of disclosure of the study information | 2015/02/09 |
| Last modified on | 2016/05/20 14:12:03 |
* 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
XELODA Special Drug Use Surveillance, XELOX as adjuvant chemotherapy for colon cancer
Acronym
XELODA Special Drug Use Surveillance
Scientific Title
XELODA Special Drug Use Surveillance, XELOX as adjuvant chemotherapy for colon cancer
Scientific Title:Acronym
XELODA Special Drug Use Surveillance
Region
| Japan |
Condition
Condition
colon cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The primary objective of this surveillance study is to understand the following conditions during actual clinical use of XELOX as adjuvant chemotherapy for colon cancer.
-ADR incidence according to patient baseline characteristics (creatinine clearance rate, etc.) before XELOX
-Early withdrawal of XELOX according to patient baseline characteristics (creatinine clearance rate, etc.) before XELOX
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ADR incidence according to creatinine clearance rate before XELOX
Key secondary outcomes
Early, 4 cycles, withdrawal of XELOX according to creatinine clearance rate before XELOX
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Of those patients that fulfill all 4 criteria below and started XELOX as adjuvant chemotherapy for colon cancer (Stage2, 3) from January 2012 to September 2014 at a medical site contracted for this surveillance study, patients enrolled retrospectively at each contracted site starting with the patient closest to the start of surveillance .
1) Patients 65 and >65 years old when starting XELOX therapy
2) Patients with serum creatinine data before XELOX therapy
3) Patients who started XELOX therapy at the specified initial dose
4) Patients with no other cancers
Key exclusion criteria
1) Patients <65 years old when starting XELOX therapy
2) Patients without serum creatinine data before XELOX therapy
3) Patients who did not start XELOX therapy at the specified initial dose
4) Patients with other cancers
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Joji Mochizuki |
Organization
Chugai Pharmaceutical Co. Ltd.
Division name
Pharmacovigilance Dept.
Zip code
Address
1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japan
TEL
03-3273-0773
mochizukijuj@chugai-pharm.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Nomura |
Organization
Chugai Pharmaceutical Co. Ltd.
Division name
Pharmacovigilance Dept.
Zip code
Address
1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japan
TEL
03-3273-0773
Homepage URL
nomuramkt@chugai-pharm.co.jp
Sponsor or person
Institute
Chugai Pharmaceutical Co. Ltd.
Institute
Department
Personal name
Funding Source
Organization
Chugai Pharmaceutical Co. Ltd.
Organization
Division
Category of Funding Organization
Profit organization
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
| 2015 | Year | 02 | Month | 09 | 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
| 2014 | Year | 12 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 09 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patent baseline characteristics:
Patient initials, sex, birth date, ID number, clinical classification (inpatient/outpatient), height, weight, reason for use, performance status (ECOG PS), stage, history of allergies, concurrent disease, baseline Ccr
Treatment status:
Daily dose, administration schedule, duration of administration, reason for change, status at CRF entry
Adverse events (AEs):
AE (Yes/No), AE term or term for abnormal laboratory test value, onset date, grade, seriousness, intervention, outcome, outcome date, causal relationship (XELODA, other factor), laboratory test value
Management information
Registered date
| 2015 | Year | 02 | Month | 04 | Day |
Last modified on
| 2016 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019102
