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NCT06704191 · ClinicalTrials.gov registry record · Phase 1
In-home Intravesical Chemotherapy for the Treatment of Bladder Cancer, INVITE Trial
A Phase 1 study of Stage 0a Bladder Cancer AJCC v8 and Stage I Bladder Cancer AJCC v8, sponsored by Mayo Clinic.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT06704191: Recruiting Phase 1 study of Stage 0a Bladder Cancer AJCC v8 and Stage I Bladder Cancer AJCC v8, sponsored by Mayo Clinic.
NCT06704191 is a Phase 1 study of Stage 0a Bladder Cancer AJCC v8 and Stage I Bladder Cancer AJCC v8 that is actively recruiting participants, run by Mayo Clinic. The registered enrollment target is 40 participants, below the 240-participant average among 7 other Stage 0a Bladder Cancer AJCC v8 trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06704191, a Phase 1 study of Stage 0a Bladder Cancer AJCC v8 and Stage I Bladder Cancer AJCC v8, is actively recruiting participants, sponsored by Mayo Clinic.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase Ib/II trial compares the safety, tolerability and acceptability of intravesical chemotherapy given at home to in-clinic administration in patients with non-muscle invasive bladder cancer. Chemotherapy drugs, such as bacillus Calmette-Guerin (BCG), gemcitabine, docetaxel, and mitomycin C, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Standard of care chemotherapy for non-invasive bladder cancer is usually given directly into the bladder through a catheter (intravesical). This process requires numerous visits and can be disruptive to the lives of patients and caregivers. Bringing cancer care to the patients with in-home intravesical therapy may help reduce the disruption to daily lives. In-home intravesical chemotherapy may be safe and tolerable and may also be preferable to in-clinic administration in patients with non-muscle invasive bladder cancer.
Primary Outcome
The incidence, type, and severity of AEs experienced will be reported. The maximum grade for each type of AE will be summarized using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Conditions Studied
Interventions
- DRUG Docetaxel
- DRUG Gemcitabine
- BIOLOGICAL BCG Solution
- PROCEDURE Cystoscopy
- OTHER Home Health Encounter
Study Locations (1)
Florida
- Mayo Clinic in Florida - Jacksonville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2025-04-21 |
| Est. Completion | 2026-06-06 |
| Phase | Phase 1 |
What NCT06704191 shows while recruiting
NCT06704191 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 240-participant average among 7 other Stage 0a Bladder Cancer AJCC v8 trials with a reported enrollment target (83% lower).
The record links to 4 conditions, with Stage 0a Bladder Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Docetaxel is the first listed.
NCT06704191 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT06704191 about?
NCT06704191 is a clinical study titled "In-home Intravesical Chemotherapy for the Treatment of Bladder Cancer, INVITE Trial". This phase Ib/II trial compares the safety, tolerability and acceptability of intravesical chemotherapy given at home to in-clinic administration in patients with non-muscle invasive bladder cancer. Chemotherapy drugs, such as bacillus Calmette-Guerin (BCG), gemcitabine, docetaxel, and mitomycin C, ...
What is the current status of trial NCT06704191?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2025-04-21. Estimated completion is 2026-06-06.
What conditions does trial NCT06704191 study?
This clinical trial studies the following conditions: Stage 0a Bladder Cancer AJCC v8, Stage I Bladder Cancer AJCC v8, Stage 0is Bladder Cancer AJCC v8, Non-Muscle Invasive Bladder Carcinoma.
What interventions are being tested in trial NCT06704191?
The interventions under investigation include: Docetaxel (DRUG), Gemcitabine (DRUG), BCG Solution (BIOLOGICAL), Cystoscopy (PROCEDURE), Home Health Encounter (OTHER).
Who is sponsoring clinical trial NCT06704191?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06704191 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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