An Additional Analysis of Data From the PARADIGM Exploratory Study (NCT02394834) in Patients With Advanced/Recurrent Colorectal Cancer

Takeda

Status: Active, not recruiting

Conditions: Colorectal Cancer

Treatments: Drug: mFOLFOX6 + bevacizumab combination therapy; Drug: mFOLFOX6 + panitumumab combination therapy

Study type: Observational

Funder types: Industry

Identifiers

NCT05030493

jRCT1031210293 (Registry Identifier)

Panitumumab-4006

Details and patient eligibility

About

The main aim of the study is to check gene change in tumor tissues with an additional analysis of the data from PARADIGM Exploratory Study, which is conducted for people with advanced/recurrent colorectal cancer.

In the PARADIGM Exploratory Study (NCT02394834), the drug being tested in this study is called Panitumumab and the main aim of this study is to check side effect from the study treatment (mFOLFOX6 + bevacizumab versus mFOLFOX6 + panitumumab therapy) and check if the study treatment improves symptoms of advanced/recurrent colorectal cancer.

Full description

This is a non-interventional study to do additional exploratory analysis of biomarkers from the PARADIGM Exploratory Study (NCT02394834), which is conducted for participants with advanced/recurrent colorectal cancer. 757 patients have enrolled in the PARADIGM Exploratory Study.

Enrollment: 787 patients

Sex: All

Ages: 20 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Participants enrolled in the PARADIGM Exploratory Study (NCT02394834) who have consented to the secondary use of samples and genomic data and have not withdrawn their consent.
2. Participants with sufficient surplus samples for gene expression/mutation and pathomorphologic (IHC, IF and/or ISH, etc.) analysis.

Exclusion criteria

Participants who are considered inappropriate for participation in this study by the research institution.

Trial design

787 participants in 2 patient groups

Group P; mFOLFOX6 + panitumumab combination therapy

Description:

OXA: 85 mg/m2/day 1 l-LV: 200 mg/m2/day 1 5-FU iv: 400 mg/m2/day 1 5-FU civ: 2400 mg/m2/day 1-3 panitumumab: 6 mg/kg mFOLFOX6 + panitumumab combination therapy, once every two weeks

Treatment:

Drug: mFOLFOX6 + panitumumab combination therapy

Group B; mFOLFOX6 + bevacizumab combination therapy

Description:

OXA: 85 mg/m2/day 1 l-LV: 200 mg/m2/day 1 5-FU iv: 400 mg/m2/day 1 5-FU civ: 2400 mg/m2/day 1-3 bevacizumab: 5 mg/kg mFOLFOX6 + bevacizumab combination therapy, once every two weeks

Treatment:

Drug: mFOLFOX6 + bevacizumab combination therapy