A study to determine the feasibility of molecular selection of therapy in patients with metastatic colorectal cancer

当肠癌不能通过手术完全切除时，或者癌症已经扩散到身体的其他部位时，可能会进行化疗，这是一种旨在杀死癌细胞的药物治疗形式。通常，给病人提供的特定化疗是根据它对病人的平均效果来选择的。在这五种药物中有一种已经被证明对结肠直肠癌有效。肠癌最常用的化疗药物是？5FU？也被称为氟尿嘧啶。我们之前的研究（FOCUS）表明，5FU与伊立替康（一种新药）联合使用效果最好，因此在本研究中将其作为标准治疗方法。这将使我们能够比较通常的治疗方法和不同的药物组合。近年来开发了两种新的治疗方法，它们不是标准的化疗。这些被称为西妥昔单抗和贝伐单抗（单克隆抗体），它们特异性地作用于与癌症生长相关的特殊蛋白质。在这个试验中，我们将比较使用所有这些药物的最佳方式，通过测试我们认为对参与者的肿瘤类型最有效的治疗方法，根据分子测试。这些检查将确定癌症的四种类型之一。对于每种类型的癌症，我们将比较不同治疗方案的效果。患者将被随机分配到三种不同的治疗方法中，以发现哪种是最好的；一个是通常的治疗过程。另外两种方案是肿瘤样本测试显示的可能比治疗这种特定类型肠癌的常规疗法更好的方案。治疗是定期进行的，每两周一次，持续至少六个月，前提是癌症得到良好控制，没有令人不快的副作用。试验的参与者也将被要求允许在未来的科学研究中使用他们已经提供的肿瘤样本。具体来说，我们将研究其他可能的蛋白质或基因测试，以预测哪种治疗方法对个别患者最有效。此外，我们将要求参与者提供血液样本以作进一步研究之用。

When cancer of the bowel is not completely removable by surgery, or when the cancer has spread to somewhere else in the body, chemotherapy, a form of drug treatment which aims to kill cancer cells, may be given. Usually, the specific chemotherapy that is offered to a patient is chosen on how well it works on average in patients.There are in all five types of medicine which have been shown to work in colorectal cancer. The most commonly used chemotherapy for bowel cancer is called ?5FU?, which is also known as ?fluorouracil?. Our previous study (called FOCUS) showed that the combination of 5FU and irinotecan, a new drug, gave the best results, so this is being used as the standard treatment in this research. This will allow us to compare the usual treatment against different combinations of medicines.In recent years two new treatments have been developed which are not standard chemotherapy. These are called cetuximab and bevacizumab (monoclonal antibodies), which specifically act on special proteins associated with the growth of the cancer. In this trial we will be comparing ways of using all these drugs in the best way by testing the treatments that we think will work best for the type of tumour that participants have, according to molecular testing. These tests will identify the cancer as one of four ?types?.For each type of cancer, we will be comparing the effects of different treatment plans. Patients will be randomly allocated to three different treatments to discover which is best; one is the usual course of treatment that would be offered. The other two plans are those which the tumour sample tests suggest might be better than the usual treatment for that particular type of bowel cancer. The treatment is given on a regular basis, every two weeks and continues for at least six months, provided the cancer remains under good control and there are no unpleasant side effects.Participants of the trial will also be asked for permission to use the tumour sample they have already given in future scientific studies. Specifically, we will look at other possible tests of proteins or of genes that may predict which treatment would work best for individual patients. In addition, we will ask participants for a blood sample for further research purposes.