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

A Population-based Prospective Study to Evaluate Clinical Behaviour, Resectability and Survival in 1st Line Metastatic Colorectal Cancer (CRC) Patients in Finland

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01531621
Acronym
RAXO
Enrollment
1000
Registered
2012-02-13
Start date
2012-02-29
Completion date
2025-12-31
Last updated
2015-03-26

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

Conditions

Metastatic Colorectal Cancer

Keywords

metastatic colorectal cancer

Brief summary

* 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

Interventions

Blood samples every 8-12 weeks

Sponsors

Pia Osterlund
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Patients with histologically confirmed CRC, who are scheduled to start or are getting first line chemotherapy for metastatic disease 2. Age \> 18 3. Metastatic disease (including locally advanced disease not amenable with surgery and/or (chemo)radiotherapy) 4. 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 5. 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.

Design outcomes

Primary

MeasureTime frameDescription
Resectability5 yearsTo assess clinical behaviour of metastatic colorectal cancer and overall resectability, postoperative morbidity and outcomes after resection

Secondary

MeasureTime frameDescription
Radiological assessment5 yearsTo radiologically assess tumour density and morphology, and assess alternative radiologic response evaluation in comparison with RECIST response criteria
Efficacy5 yearsResponse rates
Safety5 yearsNumber of adverse events

Countries

Finland

Contacts

Primary ContactPia Osterlund, MD
pia.osterlund@hus.fi+358-9-4711

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026