Summary
BICCC: Brief Intervention with Cyclophosphamide in patients with Colorectal Cancer who completed treatment
Colorectal cancer (CRC) is the third leading cause of cancer-related deaths worldwide. Although surgery cures many patients, with a success rate of over 90% in early-stage disease, ~25% of patients with intermediate-stage disease will relapse after surgery and chemotherapy, and succumb to the disease. Following standard treatment, these at-risk patients have few options available to try and prevent relapse.
Our previous studies have shown that certain white blood cells of our immune system, called T cells, can recognise molecules found only on CRC cells. We recently completed a small clinical trial in advanced CRC patients demonstrating how the T cell response to cancer molecules can be kick-started, by treatment with low-dose cyclophosphamide. This effect appeared to prolong the survival of patients, even if they had very advanced CRC by unleashing an anti-cancer immune response. Low-dose cyclophosphamide has shown an excellent safety profile with minimal side effects.
The BICCC trial will test whether a brief intervention with low-dose cyclophosphamide after intermediate-stage patients have completed their cancer treatment will help improve disease-free survival and prevent a relapse. We believe that cyclophosphamide by inducing a T cell response to cancer molecules, allows some patients to destroy cancer cells that can remain hidden after surgery and chemotherapy. These T cell anti-cancer responses will be measured in a subgroup of patients who participate in the trial.
Eligible participants in ten UK centres including Cardiff and Swansea have agreed to take part in this trial. Participants will be recruited and randomised into one of two groups:
1) Active monitoring which is standard of care (no trial treatment given)
2) Cyclophosphamide for a total of 4 weeks (weeks 1, 3, 7 and 9)
All recruited participants will be seen five times over the course of 13 weeks for monitoring and to receive their randomised treatment (tablets) for self-administration at home. The outcome of recruited participants will be followed up for a total of three years.
Cardiff University Team
Chief Investigator: Prof Andrew Godkin
Trial Manager: Dr Sope Wolffs
STU Team
Trial Governance / Lead Contact: Dr Gail Holland
Trial Support: Dr Kym Carter
Data Manager: Mr Steve Hiles
Statistician: Mr Daniel Tod
Contact Details
Eudra CT Number: 2021-003780-10;