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

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 Details

NCT ID
NCT06493370
Phase
PHASE2
Sponsor
University of Kansas Medical Center
Status
RECRUITING
Cancer Type
Bladder Cancer
Interventions
  • Intravenous ascorbic acid/vitamin C
Locations (sample)
  • Iowa City, Iowa, United States|41.66113,-91.53017
  • Kansas City, Kansas, United States|39.11417,-94.62746

Key Eligibility 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 Status (PS) 0 - 2

For full eligibility, visit ClinicalTrials.gov.

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