Metastatic Colorectal Cancer
Conditions
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
Study design
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Resectability | 5 years | To assess clinical behaviour of metastatic colorectal cancer and overall resectability, postoperative morbidity and outcomes after resection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiological assessment | 5 years | To radiologically assess tumour density and morphology, and assess alternative radiologic response evaluation in comparison with RECIST response criteria |
| Efficacy | 5 years | Response rates |
| Safety | 5 years | Number of adverse events |
Countries
Finland