Molecular selection of therapy in colorectal cancer: a molecularly stratified randomised controlled trial programme

The Medical Research Council (MRC) (UK)0 个研究点目标入组 384 人开始时间: 2013年10月16日最近更新: 2023年5月8日

适应症

试验速览

2016 Results article in http://www.ncbi.nlm.nih.gov/pubmed/26350752 pre-trial inter-laboratory analytical validation results 2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/29254887 FOCUS4-D results 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34538072/ FOCUS4-C (adavosertib) results (added 20/09/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34516759/ FOCUS4-N results for capecitabine (added 20/09/2021) 2021 Other publications in https://pubmed.ncbi.nlm.nih.gov/34516761/ editorial discussing the evidence for treatment breaks following FOCUS4-N results (added 26/01/2022)

•Registration inclusion criteria (please refer to the protocol for eligibility for randomisation)
•1. Male/female patients at least 18 years old
•2. Formalin fixed paraffin embedded (FFPE) tumour block taken prior to the commencement of standard chemotherapy and available for biomarker analysis
•3. Histologically confirmed adenocarcinoma of the colon/rectum
•4. Inoperable metastatic or locoregional disease (synchronous or metachronous)
•5. WHO performance status 0, 1 or 2
•6. Unidimensionally measurable disease RECIST 1.1 classification
•7. Have had an electronically accessible CT scan performed within 4 weeks prior to start of standard chemotherapy
•8. Platelet count < 400 x 109/L prior to start of standard chemotherapy
•9. For women of childbearing potential, a negative pregnancy test and acceptable contraceptive precautions
•10. Effective contraception for male patients if the risk of conception exists
•11. Consent for screening of an archival FFPE tumour block for biomarker analysis (PIS1 & CF1)
•13. Patients should have sufficient capacity for informed consent and provided signed informed consent

•Registration exclusion criteria (please refer to the protocol for eligibility for randomisation)
•1. Previous systemic palliative chemotherapy using a different regimen for established advanced or metastatic disease
•2. Adjuvant chemotherapy given in the last 6 months
•3. Patients with brain metastases
•4. Pregnant and lactating women

发起方

The Medical Research Council (MRC) (UK)