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NCT04046094 · ClinicalTrials.gov registry record · Phase 1
Intravenous (IV) Vitamin C With Chemotherapy for Cisplatin Ineligible Bladder Cancer Patients
A Phase 1 study of Bladder Cancer, sponsored by University of Kansas Medical Center.
- Active
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 3
- Study locations
NCT04046094: Active Phase 1 study of Bladder Cancer, sponsored by University of Kansas Medical Center.
NCT04046094 is a Phase 1 study of Bladder Cancer that is active but no longer recruiting, run by University of Kansas Medical Center. The registered enrollment target is 12 participants, below the 12,754-participant average among 175 other Bladder Cancer trials with a reported enrollment target (100% lower). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04046094, a Phase 1 study of Bladder Cancer, is active but no longer recruiting, sponsored by University of Kansas Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 3
- Study locations
Study Summary
Bladder cancer is a common disease with high rates of mortality, especially at advanced stages. Neo-adjuvant cisplatin-based chemotherapy (NAC) followed by radical cystectomy is considered standard of care for patients with muscle invasive disease, as NAC improves surgical outcomes in these patients. However, some patients are ineligible for cisplatin-based chemotherapy due to other medical issues. Although a combination of carboplatin and gemcitabine has been used with limited success, most patients proceed directly to cystectomy without realizing the potential survival benefit afforded by NAC. Intravenous ascorbate (vitamin C) administration (IVC) has been shown to improve both carboplatin and gemcitabine-based therapy in other models. This trial will add IVC to gemcitabine/carboplatin chemotherapy to evaluate whether co-treatment will increase therapeutic efficacy.
Primary Outcome
Post treatment specimen pathology results evaluated per the WHO TNM staging system. The staging system is a qualitative assessment based on the results of the physical exam, biopsy, imaging tests, and the results of surgery. The earliest stage cancers are called stage 0 (or carcinoma in situ), and then range from stages I (1) through IV (4). As a rule, the lower the number, the less the cancer has spread. A higher number, such as stage IV, means a more advanced cancer.
Conditions Studied
Interventions
- DRUG Ascorbic Acid
Study Locations (3)
Kansas
- The University of Kansas Cancer Center (KUCC) - Fairway
- The University of Kansas Medical Center - Kansas City
- The University of Kansas Cancer Center, Westwood Campus - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2019-10-17 |
| Est. Completion | 2026-08 |
| Phase | Phase 1 |
What the registry record for NCT04046094 still lists
NCT04046094 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 12,754-participant average among 175 other Bladder Cancer trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Bladder Cancer appearing as the primary indexed condition, and to 1 intervention - of which Ascorbic Acid is the first listed.
NCT04046094 reports a single indexed study location in Kansas.
Frequently Asked Questions
What is clinical trial NCT04046094 about?
NCT04046094 is a clinical study titled "Intravenous (IV) Vitamin C With Chemotherapy for Cisplatin Ineligible Bladder Cancer Patients". Bladder cancer is a common disease with high rates of mortality, especially at advanced stages. Neo-adjuvant cisplatin-based chemotherapy (NAC) followed by radical cystectomy is considered standard of care for patients with muscle invasive disease, as NAC improves surgical outcomes in these patients...
What is the current status of trial NCT04046094?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2019-10-17. Estimated completion is 2026-08.
What conditions does trial NCT04046094 study?
This clinical trial studies the following conditions: Bladder Cancer.
What interventions are being tested in trial NCT04046094?
The interventions under investigation include: Ascorbic Acid (DRUG).
Who is sponsoring clinical trial NCT04046094?
This trial is sponsored by University of Kansas Medical Center, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04046094 being conducted?
This trial has 3 study locations across Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04046094's enrollment target sits among peer trials
12 165th of 175 higher than 10 of 175 other Bladder Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bladder Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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