ISRCTN12509361已完成未知
BRAVO: High risk bladder cancer: A randomised controlled feasibility study of radical cystectomy against intra-vesical immunotherapy
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 50
研究概览
简要总结
2017 Protocol article in https://pubmed.ncbi.nlm.nih.gov/28801444/ protocol (added 27/11/2020) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33332191/ results (added 17/08/2021)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Inclusion criteria as of 23/03/2017:
- •1. Male or female aged = 18 years old.
- •2. Patients with a new diagnosis of high-risk (high grade or grade 3) non-muscle invasive urothelial carcinoma (staged as either pTa, pTis or pT1). Patients with previous low grade NMIBC are suitable.
- •3. The tumour is either solely urothelial cell carcinoma or has urothelial cell carcinoma as the majority histological component.
- •4. In addition to the HRNMIBC bladder tumour, there needs to be one or more risk factor from:
- •4.1. Presence of pTis in the bladder
- •4.2. Presence of pTis in the prostatic urethra
- •4.3. Lymphovascular invasion
- •4.4. Vascular invasion
- •4.5. Residual Grade 3/High grade UCC on re-resection (or initial TURBT if no re-resection)
- •4.6. Multifocal disease (>3 tumours at initial resection)
- •4.7. Young age (<65 years old)
- •4.8. Initial tumour Size > 3cm (or >5g in histology specimen)
- •4.9. pT1 stage
- •5. Either re-resection of the bladder (following the initial diagnostic TURBT) within 3 months prior to randomisation confirming the absence of muscle invasion
- •5.1. The initial diagnostic TURBT biopsy contains muscle, AND
- •5.2. The radiological and pathological stage assessment are in agreement regarding stage and absence of muscle invasion, AND
- •5.3. A re-resection is not appropriate in the opinion of the treating clinician AND
- •5.4. The initial TURBT is within 3 months prior to randomisation
- •6. CT or cross sectional imaging of the abdomen and pelvis within the year prior to starting treatment.
- •7. Imaging of the lungs and thorax within 3 months prior to randomisation.
- •8. Suitable and fit for both mBCG and RC as determined by the treating clinician
- •9. Central MDT pathological review agrees diagnosis
- •10. If female, must be (as documented in patient notes):
- •10.1. Postmenopausal (no menses for 12 months without an alternative medical cause), or
- •10.2. Surgically sterile (hysterectomy, bilateral salpingectomy or bilateral oophorectomy), or
- •10.3. Using acceptable contraception2 (which must be continued for 7 days after the last dose of BCG or until RC is carried out). Women of child bearing potential must undergo a pregnancy test before randomisation.
- •10.4. Not breast feeding
- •Original inclusion criteria:
- •1. Male or female aged = 18 years old
- •2. Patients with a new diagnosis of high-risk (high grade or grade 3) non-muscle invasive urothelial carcinoma (staged as either pTis, pTa or pT1). Patients with previous low grade NMIBC are suitable
- •3. The tumour is either solely urothelial cell carcinoma or has urothelial cell carcinoma as the majority histological component
- •4. In addition to the HRNMIBC bladder tumour, there needs to be one or more risk factor from:
- •4.1. Presence of pTis in the bladder
- •4.2. Presence of pTis in the prostatic urethra
- •4.3. Lymphovascular invasion
- •4.4. Vascular invasion
- •4.5. Residual Grade 3/High grade UCC on re-resection
排除标准
- •1. Solely non-urothelial or variant urothelial pathology
- •2. Unable or not willing to give informed consent
- •3. Previous high risk (high grade or grade 3) NMI or invasive bladder cancer
- •4. Any previous treatment with intravesical BCG
- •5. Any other malignancy (excluding non-melanomatous skin cancer, low-risk prostate cancer and prior low risk bladder cancer)
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