Clinical trial NCT01531621: A Population-based Prospective Study of Metastatic Colorectal Cancer (CRC) Patients in Finland
Official title: A Population-based Prospective Study to Evaluate Clinical Behaviour, Resectability and Survival in 1st Line Metastatic Colorectal Cancer (CRC) Patients in Finland
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Metastatic Colorectal Cancer
Keywords: metastatic colorectal cancer
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2012-02-13
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with metastatic cancer of the colon or rectum

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


Eligibility 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. No blood sampling, nor contacting of patients will be performed.

Primary outcomes:
measure: Resectability
timeFrame: 5 years
Secondary outcomes:
measure: Efficacy
timeFrame: 5 years
measure: Safety
timeFrame: 5 years
measure: Radiological assessment
timeFrame: 5 years
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Department of Oncology
Study officials:
affiliation: Helsinki University Central Hospital
name: Pia Osterlund, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Uutela A, Osterlund E, Halonen P, Kallio R, Algars A, Salminen T, Lamminmaki A, Soveri LM, Ristamaki R, Lehtomaki K, Stedt H, Heerva E, Muhonen T, Kononen J, Nordin A, Ovissi A, Kytola S, Keinanen M, Sundstrom J, Nieminen L, Makinen MJ, Kuopio T, Ristimaki A, Isoniemi H, Osterlund P. Resectability, conversion, metastasectomy and outcome according to RAS and BRAF status for metastatic colorectal cancer in the prospective RAXO study. Br J Cancer. 2022 Sep;127(4):686-694. doi: 10.1038/s41416-022-01858-8. Epub 2022 May 24.
citation: Uutela A, Ovissi A, Hakkarainen A, Ristimaki A, Lundbom N, Kallio R, Soveri LM, Salminen T, Algars A, Halonen P, Ristamaki R, Nordin A, Blanco Sequeiros R, Rinta-Kiikka I, Lantto E, Virtanen J, Paakko E, Liukkonen E, Saunavaara J, Ryymin P, Lammentausta E, Osterlund P, Isoniemi H; RAXO Study Group. Treatment response of colorectal cancer liver metastases to neoadjuvant or conversion therapy: a prospective multicentre follow-up study using MRI, diffusion-weighted imaging and 1H-MR spectroscopy compared with histology (subgroup in the RAXO trial). ESMO Open. 2021 Aug;6(4):100208. doi: 10.1016/j.esmoop.2021.100208. Epub 2021 Jul 26.