Chemoradiation for Bladder Preservation After Complete Response to Neoadjuvant Chemotherapy

Bladder Cancer Clinical Trial

Official title: A Phase II Study of Chemoradiation for Bladder Preservation in Patients With Muscle Invasive Bladder Carcinoma After Complete Response to Neoadjuvant Chemotherapy

Status Terminated

Clinical Trial Summary

Bladder preservation in patients with complete response after neoadjuvant chemotherapy will lead to equivalent or superior relapse free rates compared to cystectomy rates from historical controls.

Clinical Trial Description

1. Transurethral Resection of the Bladder Tumor (TURBT) and Cystoscopy performed by participating urologist:

• cystoscopic evaluation

• bimanual examination under anesthesia,

• as thorough as possible a transurethral resection (TUR) of the bladder tumor,

• and a biopsy of the prostatic urethra including both mucosa and stroma using a resection loop.

2. Neoadjuvant Chemotherapy, per standard of care: All patients will receive the neoadjuvant course of chemotherapy. The recommended neoadjuvant chemotherapy regimen consists of Gemcitabine and Cisplatin given on a 21-day cycle.This regimen will begin within 8 weeks following the TURBT and cystoscopic evaluation by the urologic surgeon;

3. Post-Neoadjuvant Evaluation: This evaluation will take place ≤ 6 weeks following the completion of the neoadjuvant chemotherapy. Evaluation will include:

• urine cytology,

• cystoscopy,

• tumor site transurethral biopsy,

• and bimanual examination after biopsy

• and biopsy of TURBT site

4. For subjects with complete response to neoadjuvant chemotherapy: Chemoradiation within 6 weeks after post-neoadjuvant evaluation. Intensity Modulated Radiation Therapy (IMRT/VMAT), and concurrent Cisplatin therapy, per standard of care; OR

5. For subjects with pT1 or worse tumor response to neoadjuvant chemotherapy: Radical Cystectomy within 12 weeks after post-neoadjuvant evaluation;

6. Post-Consolidation Endoscopic Evaluations: The first post-treatment evaluation will be 30 days +/- 14 days within the end of chemoradiation, surgery or at progression. Subsequent cystoscopic evaluation will be every three months in the first year, every four months in the second year, and every six months in the third year (all evaluations to occur +/- 14 days). Each evaluation will include serum, plasma, whole blood, urine cytology. ;

Related Conditions & MeSH terms

• Bladder Cancer
• Bladder Carcinoma
• Carcinoma
• Muscle Invasive Bladder Carcinoma
• Transition Cell Cancer
• Urinary Bladder Neoplasms

• NCT number: NCT02145390
• Study type: Interventional
• Source: University of Miami
• Status: Terminated
• Phase: N/A
• Start date: January 5, 2016
• Completion date: April 25, 2017