A population-based prospective study to evaluate clinical behaviour, resectability and survival in metastatic colorectal cancer patients in Finland - RAXO

Conditions: Therapeutic area: Diseases [C] - Cancer [C04]
MedDRA version: 14.0Level: LLTClassification code 10052362Term: Metastatic colorectal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic colorectal cancer

Registration Number: EUCTR2011-003158-24-FI

Lead Sponsor: Pia Österlund and Helena Isoniemi

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 1000

Inclusion Criteria

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 without blood sampling and contacting of patients

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

None

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess clinical behaviour of metastatic colorectal cancer and overall resectability, postoperative morbidity and outcomes after resection;Secondary Objective: - To assess treatments for mCRC<br>- 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)<br>- To radiologically assess tumour density and morphology, and assess alternative radiologic response evaluation in comparison with RECIST response criteria<br>- 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<br>;Primary end point(s): clinical behaviour of mCRC and the overall resectability rate, postoperative morbidity and outcomes after resection;Timepoint(s) of evaluation of this end point: End of study, estimated 2013

Secondary Outcome Measures