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Contact Information:

Prof Andrew Godkin
+44 2920 687003
godkinaj@cardiff.ac.uk


Dr Sope Wolffs
+44 29 2068 7060
BICCC@cardiff.ac.uk


Dr Gail Holland
-
BICCC@swansea.ac.uk


More information about this study, what is involved and how to take part can be found on the study website.

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Be Part of Research - Trial Details - Short treatment with the drug cyclophosphamide in bowel cancer
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Short treatment with the drug cyclophosphamide in bowel cancer

Recruiting

Open to: All Genders

Age: Adult

Glasgow Manchester Cardiff Oxford Cardiff Liverpool Lincoln

Medical Conditions

Stage II-IVA diagnosed colorectal cancer

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

13 Sep 2024 12 Mar 2026

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.


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.

Who can participate?
Eligible patients will be approached in approximately 10 centres across the UK including Wales, England and Scotland (500 participants; 250 participants in each arm).

You can take part if:



You may not be able to take part if:


1. Creatinine level >1.5 Upper Limit of Normal (ULN)2. Bilirubin level >1.5 ULN, Alkaline Phosphatase/Alanine Aminotransferase >2.5 ULN3. Haemoglobin <90 g/L4. Diagnosed as being immunosuppressed, receiving oral steroids (> prednisolone 10 mg daily) (nasal sprays and inhalers are permitted) or receiving other immunosuppressive therapy5. Uncorrected urinary tract obstruction or active urinary tract infection6. Participant has clinically active autoimmune disease requiring treatment to suppress autoinflammation7. Known underlying inflammatory bowel disease that is considered to be the key aetiological agent in the development of the CRC8. “Currently active” second malignancy, other than non-melanoma skin cancer and previously diagnosed prostate cancer which is stable clinically ≥ for more than 5 years with or without hormone treatment. (Participants are not considered to have a "currently active” malignancy if they have completed therapy ≥ more than 5 years previously and have no known evidence of residual or recurrent disease)9. Evidence of significant clinical factor/s or laboratory finding which in the opinion of the investigating physician makes it undesirable for the patient to participate in the trial 10. No participant should have a serious or uncontrolled intercurrent infection or be HIV positive11. A contra-indication to taking CPM:11.1. Hypersensitivity to CPM, any of its metabolites, or to other components of the tablet11.2. Acute infections11.3. Bone-marrow aplasia11.4. Acute urothelial toxicity from cytotoxic chemotherapy or radiation therapy11.5. Pregnancy - participants of childbearing potential must agree to wait 6 months after stopping CPM before attempting to conceive a child. 12. Medications not permitted before, during and after the trial: 12.1. Anti-fungal drugs (4 weeks before/after or during trial treatment)12.2. Anti-viral drugs (4 weeks before/after or during trial treatment)12.3. Chemotherapy (4 weeks before/after trial treatment start)12.4. Hormone therapy (4 weeks/after before and during trial treatment)12.5. Adrenalin (4 weeks before/after and during trial treatment)12.6. Immunosuppressive agents (4 weeks before/after and during trial treatment)


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Beatson West of Scotland Cancer Centre
    1053 Great Western Road
    Glasgow
    G12 0YN
  • The Christie NHS Foundation Trust
    550 Wilmslow Road Withington
    Manchester
    M20 4BX
  • University Hospital of Wales
    Heath Park
    Cardiff
    CF14 4XW
  • Churchill Hospital
    Old Road Headington
    Oxford
    OX3 7LE
  • Velindre Cancer Centre
    Velindre Road
    Cardiff
    CF14 2TL
  • Royal Liverpool University Hospital
    Prescot Street
    Liverpool
    L7 8XP
  • Lincoln County Hospital
    Greetwell Road
    Lincoln
    LN2 5QY

Benefits:
We cannot guarantee that there will be any direct benefits to you if you choose to take part in the BICCC trial. Some studies have shown that patients who take part in clinical trials may have better outcomes overall and that hospitals which are active in clinical research have better patient care outcomes. Some people also find the additional appointments with medical staff helpful. It is hoped that treatment with low-dose cyclophosphamide may help slow down the relapse (growth) of any leftover cancer cells if they are present, but we cannot say for certain whether this will be the case for those allocated to receive it. Your participation will also provide information about the trial treatment and colorectal cancer that may change the way we treat patients in the future.
Risks:
1. Trial treatment related side-effects:
Cyclophosphamide (50mg twice a day) should not result in significant toxicities as confirmed in our clinical trial TaCTiCC, and studies carried out by other groups which have demonstrated its safety. At this low-dose, cyclophosphamide treatment is unlikely to cause suppression of immune responses. However, higher doses have been linked to immune suppression which can lead to serious infections. Patients with immunosuppression or severe infections will be excluded from the trial. Participation will be restricted for patients with severe impairment of bone marrow function, renal and hepatic failure. Patients' liver and renal function as well as blood count will be assessed during the trial screening process.
Cyclophosphamide has the potential to cause harm to the reproductive system as well as to unborn children. Female participants of childbearing potential will take pregnancy tests before the start of cyclophosphamide. All patients of childbearing potential will be required to use contraception as necessary through the treatment course and 12 months after treatment.
Good communication between patients and the local research team can help to ensure that patients are aware of any potential side effects. Participant information sheets will advise of the potential risks for the trial. Adverse events will be monitored by the trial team and reported to the relevant committees and regulatory bodies.
Patients will need to attend 5 additional hospital visits to receive their tablets, have their health and side effects monitored and provide blood samples. Patients from Swansea, Bath and Bristol will be offered the opportunity to travel to Cardiff for their trial treatment/monitoring. This will give this subset of patients (~100 local to Cardiff) the chance to participate in the optional translational immune response analysis (secondary and tertiary endpoint). This is essential as the blood samples need to be analysed rapidly. It will be communicated to these patients that this an optional part of the trial. This subset of patients will be reimbursed for their travel.
Patients in the active monitoring arm will be offered 2 telephone follow-up appointments at the discretion of the PI.
3. Keeping track of medication schedules and symptoms: Patients will be required to self-administer their medication twice a day and asked to keep a diary to log their symptoms, which can be time-consuming and difficult to remember. Local research team will explain the process of self-administration to the participants, and hand out, explain and review patient diaries to ensure patients understand their medication schedules and the process of logging symptoms.
Blood tests are considered safe with very minimal risks. Possible adverse events of blood collection are tenderness/pain (mild and short-lived), bleeding/bruising, or feeling faint. Trained staff will perform the blood collection procedures using routine standard practices which address all the highlighted risks and ensure patient wellbeing at all times.
All recruited patients will be assigned a unique patient identification number. All trial data will be stored under the provisions of GDPR 2018. Any clinical information that leaves the hospital will have names and addresses removed to prevent participant identification.
The trial will be clearly explained to all participants using the information sheet which has been reviewed by a patient representative. The patient information sheet and consent form will be provided in English (and Welsh on request).

Dr Sope Wolffs
+44 29 2068 7060
BICCC@cardiff.ac.uk


Dr Gail Holland
-
BICCC@swansea.ac.uk


Prof Andrew Godkin
+44 2920 687003
godkinaj@cardiff.ac.uk



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by Cardiff University and funded by Cancer Research Wales.



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Read full details for Trial ID: ISRCTN12508004

Or CPMS 62905

Last updated 27 January 2025

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