Response evaluation after neoadjuvant chemotherapy for muscle invasive bladder cancer
- Conditions
- Muscle-invasive bladder carcinoma
- Registration Number
- NL-OMON25664
- Lead Sponsor
- ot applicable
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 180
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.
- 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
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The correlation between the clinical response (as assessed by clinical variables, radiological imaging, urine cytology and histological examination on per-operative TUR) and the final pathological response in the radical cystectomy (and lymph-node) resection specimen.
- Secondary Outcome Measures
Name Time Method 1. The number of pathological complete responses (defined as ypT0N0 or ypTaN0 disease) after neo-adjuvant chemotherapy, 2. The number of participants in whom radical cystectomy could have been withheld if imaging, urine cytology and histological examination on transurethral resection was not followed by radical cystectomy, 3. Predictors of pathological complete response such as age, gender, clinical tumor stage, histological subtype, tumor size, radiological imaging, and a wideset of tissue and liquid biopsy genetic biomarkers.