The accuracy of detecting residual disease following neo-adjuvant chemotherapy in patients with muscle-invasive bladder cancer

Completed

• Conditions: Bladder cancer; Muscle invasive urothelial cell carcinoma of the bladder; 10004994

• Registration Number: NL-OMON50035
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 180

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 <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.

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,

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The correlation between the clinical response during and after neo-adjuvant<br /><br>chemotherapy (as assessed by clinical variables, radiological imaging, urine<br /><br>cytology and histological examination on peroperative TUR) and the final<br /><br>pathological response in the radical cystectomy (and lymph-node) resection<br /><br>specimen.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. The number of pathological complete responses (defined as ypT0N0 or ypTaN0<br /><br>disease) after neo-adjuvant chemotherapy,<br /><br><br /><br>2. The number of participants in whom RC could have been withheld if clinical<br /><br>response evaluation (CRE) and histological examination of TUR material after<br /><br>neo-adjuvant chemotherapy correctly predicted a pathological complete response,<br /><br><br /><br>3. Predictors of complete pathological response such as age, gender, clinical<br /><br>tumor stage, histological subtype, tumor size, radiological imaging, and a<br /><br>wideset of tissue and liquid biopsy genetic biomarkers.</p><br>