An Observational Study of CPT-11 Based Regimens and UGT1A1 Genotypes in Metastatic Colorectal Cancer (mCRC)

Daiichi Sankyo

Status: Completed

Conditions: Metastatic Colorectal Cancer

Treatments: Drug: CPT-11 based regimens

Study type: Observational

Funder types: Industry

Identifiers

NCT01039506

TOP009-061

090945 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to examine the correlation between UGT1A1 genotypes and the efficacy of CPT-11 based regimens (FOLFIRI, CPT-11+S-1, CPT-11) for patients with metastatic colorectal cancer.

Enrollment: 1,376 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Metastatic colorectal cancer (adenocarcinoma)
• UGT1A1 genotyped patients
• Patients to receiving FOLFIRI, CPT-11+S-1 and CPT-11 alone therapy (with or without molecular targeted agents)

Exclusion criteria

• Contraindication of CPT-11
• Eastern Cooperative Oncology Group (ECOG) Performance Score (PS) 3-4
• Patients to receiving CPT-11 as adjuvant chemotherapy
• History of pelvic irradiation

Trial design

1,376 participants in 1 patient group

UGT1A1 genotyped patients

Description:

UGT1A1 genotyped patients receive CPT-11 based regimens

Treatment:

Drug: CPT-11 based regimens