NL-OMON25664招募中不适用
The accuracy of detecting residual disease following neo-adjuvant chemotherapy in patients with muscle-invasive bladder cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 180
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •18 year and older
- •- Able to understand patient information form (PIF)
- •- Written informed consent, on study participation and for genomic testing
- •- Histological diagnosis of muscle-invasive bladder carcinoma i.e. cT2-T4a, WHO G1-G3 grade urothelial cell carcinoma of the bladder, locally confined or locally advanced
- •- Predominant histology is urothelial cell carcinoma (>50%)
- •- No evidence of regional or distant metastases, except for a single node in the surgical template of extended pelvic lymph-node dissection (cN1), on staging FDG-PET/CT before initiation of neo-adjuvant chemotherapy
- •- Indication for neo-adjuvant chemotherapy and radical cystectomy, as determined by local multidisciplinary tumor board,
- •- Cisplatin-based combination chemotherapy, i.e. ddMVAC or Gem-Cis per local hospital protocol
- •- Clinical response evaluation (CRE) by CT abdomen/thorax with contrast after the second cycle of neo-adjuvant chemotherapy (CRE1), and after completion of neo-adjuvant chemotherapy (CRE2) should show stable disease or a partial local radiological response (subgroup 1)
- •- CRE1 or CRE2 by CT scanning should show no evidence of residual tumor disease 9a complete radiological response), which is defined as pelvic lymph nodes <10 mm in diameter showing no contrast enhancement and a bladder wall of <10 mm showing no contrast enhancement (RECIST criteria)(subgroup 2), - CRE1 or CRE2 by CT scanning should show no evidence of pulmonary, osseous, hepatic, or non-regional lymph-node metastases.
排除标准
- •- Patients unfit to receive neo-adjuvant chemotherapy as assessed by Galsky criteria
- •- Less than four courses of neoadjuvant chemotherapy received,
- •- Not willing or not fit enough to undergo radical cystectomy
- •- Concomitant extensive carcinoma in situ at diagnosis
- •- Poor kidney function with a CrCl (calculated or measured) <60 mL/min
- •- Concomitant tumors of the upper urinary tract
- •- Tumors of the urachus
- •- A known additional malignancy with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma), cervical cancer in situ that have undergone potentially curative therapy
研究者
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