CompletedNot Applicable

Identification of New Patient Stratification Tools in MSS RAS mt mCRC

Germany, Ireland, Spain29 participantsStarted 2018-09-19

Plain-language summary

This is a translational, multicentre and multinational study. The aim of this study is to identify new patient stratification tools in microsatellite stable RAS mutant metastatic Colorectal Cancer

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Ability to give signed informed consent prior to any study specific procedures and willing and able to comply with the protocol,
. Age ≥ 18 years,
. ECOG status of ≤ 2,
. At least 16 weeks of life expectancy at time of entry into the study.
. Histologically confirmed stage IV MSS RAS mt mCRC as per standard diagnostic tests,
. Unresectable and measurable disease (at least one measurable target lesion) as per clinical and radiologic criteria (RECIST v.1.1),
. No prior chemotherapy and/or radiation therapy for CRC administered in the metastatic setting,
. Scheduled to receive or receiving SOC chemotherapy with fluoropyrimidines and oxaliplatin +/- bevacizumab (baseline blood sample should be collected and questionnaires completed during pre-screening and before chemotherapy initiation),

Exclusion criteria

. Patient with CRC that has received any therapy for CRC before:
. surgical resection of tissue that would be utilised in this study

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Stratification Tools

Timeframe: 4 years

Trial details

NCT IDNCT03699111

SponsorCancer Trials Ireland

Sponsor typeNETWORK

Study typeOBSERVATIONAL

Primary completion2022-04-01

View on ClinicalTrials.gov More Advanced Colorectal Cancer trials