Brief Intervention with Cyclophosphamide in Colorectal Cancer
Research type
Research Study
Full title
Brief Intervention with Cyclophosphamide in Patients with Colorectal Cancer Who Completed Treatment (BICCC)
IRAS ID
1004377
Contact name
Andrew Godkin
Contact email
Sponsor organisation
Cardiff University
Eudract number
2021-003780-10
ISRCTN Number
ISRCTN12508004
Research summary
Bowel cancer is one of the leading causes of cancer-related deaths worldwide. In the early stages of the disease, many patients can be cured with surgery. However, in the later stages, bowel cancer can return or progress even after surgery and chemotherapy. One potential way of preventing relapse is by making the patient’s immune system better at detecting and destroying any cancer cells that might remain after treatment.
T cells are a type of white blood cell that play a key role in the immune system. They identify and destroy infected or cancerous cells in the body by recognising specific proteins found on the cells’ surface. Previous studies showed that T cells can recognise proteins expressed by bowel cancer cells. We have also completed a small clinical trial which demonstrated how using the drug, cyclophosphamide at a low dose can kick-start the T cell response to cancer cells, prolonging the survival of patients with very advanced bowel cancer. At this low dose, cyclophosphamide was found to be very safe.
The BICCC trial aims to test whether giving a low dose of cyclophosphamide for 4 weeks to stage 2 - 4 bowel cancer patients who have completed surgery/chemotherapy can help prevent relapse. Since cyclophosphamide kick-starts T cell response to cancer cells, we believe that this response may allow some patient’s immune system to destroy any remaining bowel cancer cells. Blood samples will be taken to study these anti-cancer responses in a small group of trial participants.
Eligible patients will be approached in 10 centres across the UK including Cardiff and Swansea. Patients will be randomly assigned to either receive the trial treatment (low-dose cyclophosphamide) or be monitored by their clinical team for 13 weeks. All recruited patients will have 5 trial visits for monitoring and to receive tablets which they will take at home. Patients will be followed for three years, allowing us to measure if cyclophosphamide can prevent disease relapse.REC name
London - Fulham Research Ethics Committee
REC reference
23/LO/0538
Date of REC Opinion
15 Sep 2023
REC opinion
Further Information Favourable Opinion