Brief intervention with cyclophosphamide in patients with colorectal cancer who completed treatment (BICCC)

Cardiff University0 sites500 target enrollmentNovember 16, 2023

Overview

No summary available.

Registry

who.int

Start Date

November 16, 2023

End Date

September 3, 2028

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

•1\. Ability and willingness to provide written informed consent
•2\. Willing and able to comply with the trial visits and undergo treatment as scheduled
•3\. Age \= 50 years
•4\. Clinical diagnosis of colorectal cancer stage II – IVA
•5\. Completed treatment by surgery ± adjuvant chemotherapy and deemed ‘cured’
•6\. For participants receiving adjuvant chemotherapy:
•6\.1\. Last dose of chemotherapy must be completed \= 4 weeks prior to first dose of trial therapy
•6\.2\. First trial therapy dose must be started \= 4 months from last chemotherapy dose
•7\. For participants not receiving adjuvant chemotherapy surgery must be \= 6 weeks prior to first dose of trial therapy
•8\. WHO performance status 0 – 2

•1\. Creatinine level \>1\.5 Upper Limit of Normal (ULN)
•2\. Bilirubin level \>1\.5 ULN, Alkaline Phosphatase/Alanine Aminotransferase \>2\.5 ULN
•3\. Haemoglobin \<90 g/L
•4\. Diagnosed as being immunosuppressed, receiving oral steroids (\> prednisolone 10 mg daily) (nasal sprays and inhalers are permitted) or receiving other immunosuppressive therapy
•5\. Uncorrected urinary tract obstruction or active urinary tract infection
•6\. Participant has clinically active autoimmune disease requiring treatment to suppress autoinflammation
•7\. Known underlying inflammatory bowel disease that is considered to be the key aetiological agent in the development of the CRC
•8\. 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 positive