UMIN-CTR Clinical Trial

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

colon cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Chugai Pharmaceutical Co. Ltd.

Institute

Department

Personal name

Organization

Chugai Pharmaceutical Co. Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

02

Month

09

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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

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