EUCTR2012-005111-12-GB进行中（未招募）1 期
FOCUS4 – Molecular selection of therapy in colorectal cancer: a molecularly stratified randomised controlled trial programme - FOCUS4: Molecular selection of therapy in colorectal cancer
niversity College London0 个研究点目标入组 4,200 人开始时间: 2013年4月8日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 4,200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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.
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