UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016446
Receipt No. 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

* 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
Email 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
Email nomuramkt@chugai-pharm.co.jp

Sponsor
Institute Chugai Pharmaceutical Co. Ltd.
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019102

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.