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

Conditions

Metastatic colorectal cancer MedDRA version: 14.0 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Aki Uutela, Emerik Österlund, Päivi Halonen, Raija Kallio, Annika Ålgars et al. (25 authors)

British Journal of Cancer2022-05-2416 citations

10.1038/s41416-022-01858-8

Treatment response of colorectal cancer liver metastases to neoadjuvant or conversion therapy: a prospective multicentre follow-up study using MRI, diffusion-weighted imaging and <sup>1</sup>H-MR spectroscopy compared with histology (subgroup in the RAXO trial).

Uutela A, Ovissi A, Hakkarainen A, Ristimäki A, Lundbom N, Kallio R, Soveri LM, Salminen T, Ålgars A, Halonen P, Ristamäki R, Nordin A, Blanco Sequeiros R, Rinta-Kiikka I, Lantto E, Virtanen J, Pääkkö E, Liukkonen E, Saunavaara J, Ryymin P, Lammentausta E, Osterlund P, Isoniemi H, RAXO Study Group.

2021-07-2611 citations

10.1016/j.esmoop.2021.100208

Interventions

Trade Name: Levinneen suolistosyövän hoitoon hyväksytyt lääkkeet. Pharmaceutical Form:

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: None

Design outcomes

Primary

Measure	Time frame
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 - 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 ;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	—

Measure

Time frame

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 - 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 ;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

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Secondary

Measure	Time frame
Secondary end point(s): RR, FFS, PFS, and OS ;Timepoint(s) of evaluation of this end point: End of study, estimated 2013	—

Countries

Finland

Contacts

Public ContactHelsinki University Hospital

Pia Österlund and Helena Isoniemi

pia.osterlund@hus.fi35894711

Outcome results

None listed