Bladder cancer Muscle invasive urothelial cell carcinoma of the bladder
Conditions
Interventions
None listed
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - 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 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 (a complete radiological response), which is defined as pelvic lymph nodes
Exclusion criteria
Exclusion criteria: - 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 therapy,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The correlation between the clinical response during and after neo-adjuvant chemotherapy (as assessed by clinical variables, radiological imaging, urine cytology and histological examination on peroperative TUR) and the final pathological response in the radical cystectomy (and lymph-node) resection specimen. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The number of pathological complete responses (defined as ypT0N0 or ypTaN0 disease) after neo-adjuvant chemotherapy, 2. The number of participants in whom RC could have been withheld if clinical response evaluation (CRE) and histological examination of TUR material after neo-adjuvant chemotherapy correctly predicted a pathological complete response, 3. Predictors of complete pathological response such as age, gender, clinical tumor stage, histological subtype, tumor size, radiological imaging, and a wideset of tissue and liquid biopsy genetic biomarkers. | — |
Countries
Netherlands
Outcome results
None listed