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Title:
A Phase II Trial of Risk Enabled Therapy After Initiating Neoadjuvant Chemotherapy for Bladder Cancer (RETAIN BLADDER) (15-1071)
Protocol Number:
J1875
Phase:
Phase II
Physician:
Jean Hoffman-Censits
Sites:
Johns Hopkins Kimmel Cancer Center in Baltimore
Sibley Memorial Hospital
Purpose:
To evaluate the metastasis-free survival (defined as a recurrence of urothelial carcinoma that is greater than cN1 (more than one clinically suspicious pelvic lymph node) or surgically unresectable local recurrence (e.g., greater than cT4a) or M1 disease) at 2 years for all patients.To assess the feasibility of combined modality therapy (CMT) in muscle invasive bladder cancer with neoadjuvant AMVAC followed by concurrent chemoradiation with IMRT and 5-fluorouracil and mitomycin C for patients after NAC who have residual NMIBC, cT2 disease or no residual disease but also no mutations of interest•To assess the rate of any urothelial carcinoma recurrence in active surveillance patients •To assess overall survival and progression-free survival of the entire cohort•To assess toxicity during each treatment arm•To assess the proportion of patients with equal to cT1 disease after NAC•To assess bladder preservation rates with neoadjuvant AMVAC and subsequent risk-adapted treatment•To assess the feasibility of an Endoscopic Tumor Quantification System •To assess quality of life with neoadjuvant AMVAC and subsequent risk-adapted treatment•To assess genomic correlates and mutations in urinary cell-free DNA.
Eligibility:
Male or female patients equal to 18 years.Primary urothelial or predominantly urothelial carcinoma of the bladder.Histologic evidence of muscularis propria invasion.AJCC33 clinical stage T2-T3 N0M0.No radiographic evidence of lymph node positive disease as per RECIST 1.1 ( equal to 15 mm short axis diameter). Lymph node positive disease is defined as clinical lymphadenopathy on staging CT or MRI greater than 1.4 cm in the short axis. If a lymph node is greater than 1.4 cm, it has to be biopsy proven negative for the patient to be eligible. No metastatic disease (M0). ECOG performance status 0, or 1.Left ventricular ejection fraction equal to 50% by MUGA or ECHO within 6 months of study entry.Normal organ and bone marrow functionLaboratory parameters for normal organ and bone marrow function
Treatment:
The aim of our study is to evaluate a risk-adapted approach to the treatment of muscle invasive bladder cancer. We plan to sequence each baseline TURBT sample while proceeding with neoadjuvant AMVAC chemotherapy. Based on the mutational profile and the post AMVAC TURBT findings, patients will be treated with active surveillance (experimental arm), or standard of care intravesicle therapy, chemoradiation or surgery. We hypothesize that this approach will lead to non-inferior metastasis-free survival at 2 years, while preserving the bladder and thus quality-of-life for a proportion of patients.
Population:
Adult
Last Update
03/05/2019 05:03 AM