FOCUS4: Molecular selection of therapy in colorectal cancer

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 4200

Inclusion Criteria

1.Male or female patients at least 18 years old at registration
2.FFPE tumour block taken prior to the commencement of standard first-line treatment and available for biomarker analysis
3.Histologically confirmed adenocarcinoma of the small bowel or colon or rectum
4.Inoperable metastatic or locoregional disease (synchronous or metachronous)
5.WHO performance status 0, 1 or 2 (see Appendix III)
6.Disease which could be RECIST reported v1.1 classification as unidimensionally measurable disease (see Appendix IV) from the CT scan taken following inclusion criteria 7.
7.Have had an electronically accessible CT scan performed. This scan should ideally be performed just before but no more than six weeks prior to commencement of standard first-line treatment. Unavoidable delays of a few days for scheduling reasons may be approvable, but sites must contact the MRC CTU prior to registering the patient. CT scans performed a few days after the start date of standard first-line treatment may also be approvable, but only due to uncontrollable circumstances and only after discussion with the MRC CTU team and prior to registering the patient.
8.Women of child bearing potential must be willing to use adequate contraceptive measures (see Appendix V for contraindications of oral contraceptives) from registration into FOCUS4 to 7 weeks after ending first-line treatment and during, and 6 weeks after any subsequent randomised treatment in one of the FOCUS4 comparisons, should not be breastfeeding and must have a negative pregnancy test at any point prior to registration. Women of non-child bearing potential should fulfil one of the following criteria at screening:
Post menopausal as defined by:
Aged =50 years and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments
Aged <50 years and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments and with luteinising hormone and follicular stimulating hormone levels in the post-menopausal range
Documentation of irreversible surgical sterilisation by hysterectomy, and/or bilateral oophorectomy and/or bilateral salpingectomy but excludes bilateral tubal ligation
9.Male patients with partners of child bearing potential should be willing to abstain or use barrier contraception (i.e., condoms) for the duration of standard first-line treatment following registration and for 3 months after stopping any treatment administered as part of FOCUS4 (standard first line treatment, or subsequent randomised treatment). Male patients wishing to father children whilst taking standard first-line treatment and 3 months after stopping standard first-line treatment should be counselled on freezing sperm samples before starting standard first-line treatment.
10.Consent for screening of an archival FFPE tumour block for biomarker analysis
11.Patients who have already commenced on standard first-line treatment must be registered for the trial during the first 12 weeks of first-line treatment (this allows approximately 6 weeks for return of their biomarker results prior to the end of first-line treatment)
12.Patients should have sufficient capacity for informed consent assessed at the treating physicians discretion
13.Patient has provided signed informed consent

For inclusion criteria for randomisation into FOCUS4-C, please refer to section 3.3.1 of the FOCUS4-C protocol v6.0 dated 17.09.2019.

For inclusion criteria for randomisation into FOCUS4-N, pleas

Exclusion Criteria

1.Any previous systemic palliative chemotherapy for established advanced or metastatic disease except single agent capecitabine as a radiosentiser in a setting with potential curative intent such as leading to possible resection.
2.Adjuvant chemotherapy given in the 6 months prior to commencing standard first-line treatment
3.Patients with brain metastases
4.Pregnant and lactating women
5.Patients with known HIV, hepatitis B or hepatitis C infection

For exclusion criteria for randomisation into FOCUS4-C, please refer to section 3.3.2 of the FOCUS4-C protocol v6.0 dated 17.09.2019.

For exclusion criteria for randomisation into FOCUS4-N, please refer to section 3.3.2 of the FOCUS4-N protocol v5.0 dated 11.09.2019.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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