Intravenous Ascorbate Plus Gemcitabine/Carboplatin: A Novel and Cost-Effective Alternative With Evident Efficacy in Patients With Muscle Invasive Bladder Cancer

Recruiting Phase 2 Interventional Study
Bladder Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
48 (estimated)
Sponsor
University of Kansas Medical Center · Other
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About This Trial

This is a phase II, single arm, Simon two-stage design, trial, enrolling patients with cisplatin ineligible MIBC and/or those patients who decline cisplatin based NAC. Assess rates of pathologic downstaging and quality of life in MIBC cisplatin-ineligible/declined patients when IVC is added to gemcitabine-carboplatin NAC.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Ability of participant to understand this study, and participant willingness to sign a written informed consent * Consent to participate in biorepository protocol number GUB-BCR-001, KU IRB Approved HSC # STUDY00141546 * Males and females age ≥ 18 years * ECOG Performance Stat…
Contacts

KUCC Navigation

913-588-3671

kucc_navigation@kumc.edu

CONTACT

Faith Rahman

913-588-2502

frahman2@kumc.edu

CONTACT