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Chemoradiation for Bladder Preservation After Complete Response to Neoadjuvant Chemotherapy

NCT02145390 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2018-08-28

Study results available
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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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • University of Miami

    lead OTHER

Principal Investigators

  • Adrian S Ishkanian, MD · University of Miami Sylvester Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-05
Primary Completion
2017-04-25
Completion
2017-04-25

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02145390 on ClinicalTrials.gov