NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000016446

Registered date:09/02/2015

XELODA Special Drug Use Surveillance, XELOX as adjuvant chemotherapy for colon cancer

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedcolon cancer
Date of first enrollment2015/02/09
Target sample size40
Countries of recruitmentJapan
Study typeObservational
Intervention(s)

Outcome(s)

Primary OutcomeADR incidence according to creatinine clearance rate before XELOX
Secondary OutcomeEarly, 4 cycles, withdrawal of XELOX according to creatinine clearance rate before XELOX

Key inclusion & exclusion criteria

Age minimum65years-old
Age maximumNot applicable
GenderMale and Female
Include criteriaOf 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
Exclude criteria1) 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

Related Information

Contact

public contact
Name Makoto Nomura
Address 1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japan Japan
Telephone 03-3273-0773
E-mail nomuramkt@chugai-pharm.co.jp
Affiliation Chugai Pharmaceutical Co. Ltd. Pharmacovigilance Dept.
scientific contact
Name Joji Mochizuki
Address 1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japan Japan
Telephone 03-3273-0773
E-mail mochizukijuj@chugai-pharm.co.jp
Affiliation Chugai Pharmaceutical Co. Ltd. Pharmacovigilance Dept.