NCT02145390

Chemoradiation for Bladder Preservation After Complete Response to Neoadjuvant Chemotherapy

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: University of Miami · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
PROCEDURE	Transurethral Resection of the Bladder Tumor & Cystoscopy	TURBT and Cystoscopy will be performed by the participating urologist prior to start of neoadjuvant chemotherapy, per the study protocol: * Cystoscopic evaluation * Bimanual examination under anesthesia, * Transurethral resection of the bladder tumor, * Biopsy of the prostatic urethra including both mucosa and stroma using a resection loop.
RADIATION	Intensity Modulated Radiation Therapy	For subjects with complete response to neoadjuvant chemotherapy. Subjects will receive 25 daily fractions (5 weeks) of radiation therapy for 5 days a week (Monday to Friday) except on weekends or holidays, when remaining fractions will be added to the end of treatment. The overall schema is for IMRT based radiation to the entire bladder, prostate (in men) and the pelvic lymph nodes: * Pelvic lymph nodes: 45 Gy in 25 fractions at 1.8 Gy per fraction. * Whole bladder and prostate: 50 Gy in 25 fractions at 2.0 Gy per fraction. * Tumor boost area: 60-65 Gy in 25 fractions at 2.4-2.6 Gy per day * Final boost dose will be determined at the discretion of the treating physician based on normal tissue exposure and volume.
BEHAVIORAL	Expanded Prostate Cancer Index Composite Short Form 12	Quality of life questionnaire to be administered to subjects at intervals defined by the study protocol.
BEHAVIORAL	International Prostate Symptom Score	Quality of life questionnaire to be administered to subjects at intervals defined by the study protocol.

Timeline

• Start date: 2016-01-05
• Primary completion: 2017-04-25
• Completion: 2017-04-25
• First posted: 2014-05-22
• Last updated: 2018-08-28
• Results posted: 2018-08-28

Locations

1 site across 1 country: United States