ISRCTN12508004进行中（未招募）2 期
Brief intervention with cyclophosphamide in patients with colorectal cancer who completed treatment (BICCC)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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
- •9. Female participants of childbearing potential (i.e. aged 50-55 in this study and not reached the menopause (postmenopausal state is defined as no menses for 12 months without an alternative medical cause)) have a negative urine pregnancy test and are not breastfeeding
- •10. Female participants of childbearing potential and male participants with a female partner of childbearing potential must agree to use appropriate methods of contraception (male condoms, ovulation-inhibiting hormonal contraception, intrauterine device (IUD), intrauterine hormone-releasing system (IUS) or abstinence) until 6 months following the date of their final dose of trial treatment
排除标准
- •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
- •11. A contra-indication to taking CPM:
- •11.1. Hypersensitivity to CPM, any of its metabolites, or to other components of the tablet
- •11.2. Acute infections
- •11.3. Bone-marrow aplasia
- •11.4. Acute urothelial toxicity from cytotoxic chemotherapy or radiation therapy
- •11.5. 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)
研究者
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