Clinical trial

A Non-interventional Study to Assess the Safety and Efficacy of First Line Therapy With Vectibix® in Combination With FOLFIRI or FOLFOX and to Validate a Prognostic Score in Adult Patients With RAS Wild-type Metastatic Colorectal Cancer in a Real World Setting (VALIDATE)

Name

IOM-050341

Description

A safety and efficacy study of first line therapy with Vectibix® in combination with FOLFIRI or FOLFOX to validate a prognostic score in adult patients with RAS wild-type metastatic colorectal cancer in a real world setting (VALIDATE)

Trial arms

Trial start

2017-01-25

Estimated PCD

2024-01-17

Trial end

2024-01-17

Status

Completed

Treatment

Panitumumab

Patients will be scheduled to receive first line therapy with the combination of Panitumumab (6 mg / kg i.v, given once every two weeks) and FOLFIRI or FOLFOX, according to current SmPC.

Arms:

high risk, low risk, medium risk

Other names:

+ FOLFIRI or FOLFOX

Size

647

Primary endpoint

Overall Survival (OS) of pre-defined risk groups low vs. high

From date of start of first line therapy to date of death due to any cause (assessed up to 84 months)

Eligibility criteria

Inclusion Criteria: * Eligibility according to current SmPC * Signed written informed consent * Diagnosis of RAS-WT mCRC * No prior systemic therapy in the palliative setting * Aged 18 years or older Exclusion Criteria: * Any contraindication according to current SmPC * Participation in other clinical trials

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 647, 'type': 'ACTUAL'}}

Updated at

2024-04-24

1 organization

1 product

2 indications

Organization

Product

Indication

Indication