Phase I/II feasibility study of cetuximab with 5-fluorouracil (5FU) and mitomycin C or cisplatin with concurrent radiotherapy in muscle invasive bladder cancer

niversity of Birmingham0 个研究点目标入组 33 人开始时间: 2011年8月17日最近更新: 2023年1月23日

适应症

试验速览

2017 Abstract results in https://dx.doi.org/10.1200/JCO.2017.35.15_suppl.4527 (added 14/04/2022) 2020 Abstract results in https://dx.doi.org/10.1200/JCO.2020.38.6_suppl.491 (added 14/04/2022) 2021 Other publications in https://pubmed.ncbi.nlm.nih.gov/34491610/ Results of sub-study investigating whether urinary DNA analysis can be used to investigate whether treatment response is associated with tumor mutations (added 14/04/2022) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35908256/ (added 02/08/2022)

•1. Aged 18 or over
•2. Histologically proven invasive bladder carcinoma [adenocarcinoma, transitional cell carcinoma (TCC) or squamous cell carcinoma (SCC)]
•3. Localised muscle invasive carcinoma either surgically or by imaging (T2-T4a N0 M0)
•4. World Health Organisation (WHO) performance status grade 0 to 1
•5. Adequate haematological function (haemoglobin > 10g/dl; white blood cells (WBC) > 3.0x109/L; absolute neutrophils count (ANC) > 1.5x109/L; platelet count > 100,000/mm3)
•6. Adequate hepatic function {billirubin < 1.5 upper limit fo normal (ULN), Alkaline phosphatase (ALP) < 2xULN, [aspartate aminotransferase (AST)/alanine aminotransferase (ALT)] < 3.0xULN}
•7. Glomerular filtration rate (GFR) > 40 ml/min [by ethylenediamine tetraacetic acid (EDTA) clearance, 24h urine collection, or Cockcroft-Gault]
•8. Available for long-term follow-up
•9. Able to receive a radical course of radiotherapy
•10. Patient?s written informed consent
•11. Have received 3-4 cycles of neo-adjuvant chemotherapy (preferably Gemcitabine/Cisplatin) with a positive response (confirmed by cystoscopy & radiological response) with pre neo-adjuvant imaging computerised tomography (CT) scan or magnetic resonance imaging (MRI) of abdomen and pelvis.; Target Gender: Male & Female ; Lower Age Limit 18 years

•1. Uncontrolled systemic disease which would preclude the patient from participating in the study including severe or uncontrolled cardiovascular disease (congestive heart failure New York Heart Association (NYHA) III or IV, unstable angina pectoris, history of myocardial infarction within the last twelve months, significant arrhythmias
•2. Pregnant or breast feeding
•3. Concomitant or previous malignancy which is likely to interfere with protocol treatment
•4. Inflammatory bowel disease
•5. Previous pelvic radiotherapy
•6. Bilateral hip replacements compromising accurate radiotherapy planning
•7. Evidence of significant clinical disorder, or laboratory finding which, in the opinion of the investigator, makes it undesirable for the patient to participate in the trial
•8. Male and female patients (of childbearing age) not using adequate contraception
•9. Significant decrease in GFR during previous chemotherapy treatments
•10. Widespread carcinoma in situ (CIS), or CIS remote from the muscle invasive tumour
•11. Simultaneous upper tract, urethral or prostatic transitional cell carcinoma
•12. Untreated hydronephrosis
•13. Participation in another trial within the previous 30 days [except for observational studies, e.g. Bladder Cancer Prognosis Programme (BCPP)]

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