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

Metastatic Colorectal Cancer Clinical Trial

— RAXO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01531621
• Other study ID #: 2011-003158-24
• Status: Recruiting
• Phase: N/A
• First received: February 3, 2012
• Last updated: March 25, 2015
• Start date: February 2012
• Est. completion date: December 2025

Study information

• Verified date: March 2015
• Source: Helsinki University Central Hospital
• Contact: Pia Osterlund, MD
• Phone: +358-9-4711
• Email: pia.osterlund[@]hus.fi
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Other:
• Biomarker sampling
Blood samples every 8-12 weeks

Locations

Country	Name	City	State
Finland	Department of Oncology	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Pia Osterlund

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resectability	To assess clinical behaviour of metastatic colorectal cancer and overall resectability, postoperative morbidity and outcomes after resection	5 years	No
Secondary	Efficacy	Response rates	5 years	No
Secondary	Safety	Number of adverse events	5 years	Yes
Secondary	Radiological assessment	To radiologically assess tumour density and morphology, and assess alternative radiologic response evaluation in comparison with RECIST response criteria	5 years	No