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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000016446

Enrollment

Registered

2015-02-09

Start date

2015-02-09

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

colon cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
ADR incidence according to creatinine clearance rate before XELOX	—

Secondary

Measure	Time frame
Early, 4 cycles, withdrawal of XELOX according to creatinine clearance rate before XELOX	—

Countries

Japan

Contacts

Public ContactMakoto Nomura

Chugai Pharmaceutical Co. Ltd. Pharmacovigilance Dept.

nomuramkt@chugai-pharm.co.jp03-3273-0773

Outcome results