A Population-based Prospective Study of Metastatic Colorectal Cancer (CRC) Patients in Finland (RAXO)

Pia Osterlund

Status

Enrolling

Conditions

Metastatic Colorectal Cancer

Treatments

Other: Biomarker sampling

Study type

Observational

Funder types

Other

Identifiers

2011-003158-24

Details and patient eligibility

About

A population-based prospective study to evaluate clinical behaviour, resectability and survival in 1st line metastatic colorectal cancer (CRC) patients in Finland
Primary objective: To assess clinical behaviour of metastatic colorectal cancer and overall resectability, postoperative morbidity and outcomes after resection
Secondary objectives: To assess treatments for mCRC; To assess efficacy of chemotherapy and targeted drugs with overall response rates (ORR), failure free survival (FFS), progression free survival (PFS), and overall survival (OS); To radiologically assess tumour density and morphology, and assess alternative radiologic response evaluation in comparison with RECIST response criteria; To evaluate whole blood, plasma, serum and tumour block biomarkers and DNA polymorphisms that may predict drug effects, resectability and clinical behaviour of the tumour

Enrollment

1,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

Patients with histologically confirmed CRC, who are scheduled to start or are getting first line chemotherapy for metastatic disease
Age > 18
Metastatic disease (including locally advanced disease not amenable with surgery and/or (chemo)radiotherapy)
Signed written informed consent according to ICH/GCP and the local regulations (approved by the Independent Ethics Committee [IEC]) will be obtained prior to study
No informed consent will be obtained from patients participating in the data collection study obtaining data from hospital charts. No blood sampling, nor contacting of patients will be performed.