UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	XELODA Special Drug Use Surveillance, XELOX as adjuvant chemotherapy for colon cancer
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Joji Mochizuki
Organization	Chugai Pharmaceutical Co. Ltd.
Division name	Pharmacovigilance Dept.
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	Makoto Nomura
Organization	Chugai Pharmaceutical Co. Ltd.
Division name	Pharmacovigilance Dept.
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 12 Month 25 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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