NL-OMON50035已完成不适用
The accuracy of detecting residual disease following neo-adjuvant chemotherapy in patients with muscle-invasive bladder cancer - PRE-PREVENCYS
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 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
- 年龄范围
- 18 至 99（—）
入选标准
- •- 18 year and older,
- •- Able to understand patient information form (PIF),
- •- Written informed consent, on study participation and genomic testing,
- •- Histological diagnosis of MIBC, 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 RC, as determined by local
- •multidisciplenary board,
- •- Cisplatinum-based chemotherapy, i.e. ddMVAC or Gem-Cis per local hospital
- •- 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
- •(a 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,
- •he-patic, or non-regional lymph-node metastases.
排除标准
- •- Not being able to receive neo-adjuvant chemotherapy as determined by the
- •Galsky criteria,
- •- Received less than three cycles of cisplatin-based chemotherapy,
- •- Not being able to undergo RC,
- •- Concomitant extensive CIS at diagnosis,
- •- Poor kidney function, under 60 ml/min/kg,
- •- 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 (eg, breast
- •carcinoma), cervical cancer in situ that have undergone potentially curative
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