What do participants need to do: Complete an online survey
How long will it take? 15 minutes
Will participants get paid? no
Who can take part? People currently receiving colorectal cancer treatment and their carers/families
Bevacizumab: Bevacizumab (you may know it from the trade name of Avastin) increases the effectiveness of chemotherapy in some patients with colorectal cancer. However, bevacizumab is not considered sufficiently cost-effective for the NHS and, though some patients with colorectal cancer can still benefit from this drug, their doctors cannot prescribe it for them.
Blood test (Tie2): Cardiff University and The Christie NHS Foundation Trust have developed a simple blood test (Tie2), which they think can identify the patients who benefit from bevacizumab, but they need to assess its value in a clinical trial that confirms their initial findings.
They would like to know your opinion on the design of a clinical trial, which would prove whether the test works and which patients it works for. If they can prove that the test works, this would make bevacizumab more cost-effective for the NHS.
Cardiff University and The Christie NHS Foundation Trust would like to introduce bevacizumab and the Tie2 test in a trial (VALTIVE-C) in patients with metastatic colorectal cancer. By taking part in this research, participants will help them gain a better understanding of bevacizumab’s effects and limitations and build confidence in the Tie2 test so that they can tell future patients whether this drug is working for them.
They are proposing the following design:
Eligible patients with metastatic colorectal cancer will be randomly allocated to two groups who will both receive chemotherapy and bevacizumab for 8-9 weeks. At this stage both groups will have a Tie2 test. In current practice, chemotherapy would be given without the bevacizumab at this point.
Participants in Group 1 will have the result of their Tie2 results revealed, and this will be used to decide whether their chemotherapy is to be continued with or without the bevacizumab. Non-responders to bevacizumab from Group 1 will stop receiving bevacizumab, because the Tie 2 test has shown it is not working. Responders to bevacizumab, whose Tie2 test shows that treatment is working well, will continue to receive bevacizumab. In both Groups, all participants will continue chemotherapy.
In Group 2, Tie2 results will not be revealed to either clinicians or participants, and the treating doctor will decide on their ongoing treatment. It is important to note that the decision to continue chemotherapy or not will not depend upon the Tie2 test but will be based upon standard decision processes, such as CT scans.
In this trial, only the non-responders in Group 1 will stop bevacizumab. The Group 2 participants will continue bevacizumab, even if the Tie2 test results, which will be not known by participants or clinicians until the end of the trial, suggest that they are not responding to treatment. This is necessary to prove conclusively that the Tie2 test is effective and should be implemented in the NHS.
They would like people with colorectal cancer or any other type of cancer share their opinion about their proposed study by completing an online questionnaire, which will not take longer than 15 mins:
https://app.onlinesurveys.jisc.ac.uk/s/cardiff/valtive-c-trial-patients-and-public-view-questionnaire
Your contribution would help them be more confident when presenting their proposal to potential funders.
Please note that some of your answers may be quoted in their application to funders and trial reports. All quotes will be anonymised. No identifiable information (your name and/or email address) will be shared outside the VALTIVE-C trial team.
