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New treatment option for Malignant Neoplasm of Bladder
Official title Partial Cystectomy & Extended Pelvic Lymph Node Dissection With SOC Perioperative Systemic Therapy
ClinicalTrials.gov ID: NCT06290687
What this study is testing
What is Neoadjuvant Chemotherapy?
Neoadjuvant Chemotherapy is an investigational medicine, being studied as a potential treatment for malignant neoplasm of bladder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to determine if a partial cystectomy with extended pelvic lymph node removal will be effective at treating Muscle-Invasive Bladder Cancer instead of a complete cystectomy with extended pelvic lymph node removal. This clinical trial aims to determine the safety and oncologic efficacy of the intervention, and to examine patient-reported quality of life outcomes in participants.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older
You may be able to join if
- people must have histologically confirmed urothelial carcinoma of the bladder, clinical stage T2-3N0M0. Micropapillary, glandular, squamous, and...
- people must have unifocal or limited multifocal disease amenable to complete surgical resection with partial cystectomy, as judged by the treating...
- Age \>18 years. Because of the rarity of this disease and limited data on treatment how well it works in people 18 years of age, children are...
- Performance status - Karnofsky Performance Status ≥70 or Eastern Cooperative Oncology Group (ECOG) performance status Grade 0 or 1.
- people must have normal organ and marrow function as defined below:
You likely can't join if
- Presence of hydronephrosis.
- Presence of multifocal disease that is not amenable to complete resection with partial cystectomy.
- Presence of distant carcinoma in situ.
- Presence of clinical N+ or M+ disease.
- Presence of cT4+ disease.
- Non-urothelial histology.
See the full eligibility criteria
- people must have histologically confirmed urothelial carcinoma of the bladder, clinical stage T2-3N0M0. Micropapillary, glandular, squamous, and sarcomatoid histologic variants of urothelial carcinoma are allowed.
- people must have unifocal or limited multifocal disease amenable to complete surgical resection with partial cystectomy, as judged by the treating urologic oncologist.
- Age \>18 years. Because of the rarity of this disease and limited data on treatment how well it works in people 18 years of age, children are excluded from this study.
- Performance status - Karnofsky Performance Status ≥70 or Eastern Cooperative Oncology Group (ECOG) performance status Grade 0 or 1.
- people must have normal organ and marrow function as defined below:
- Total bilirubin within normal limits
- AST (SGOT) ≤ 2.5 X institutional upper limit of normal
- ALT (SGPT) ≤ 2.5 X institutional upper limit of normal
- Bone marrow:
- Absolute neutrophil count (ANC) ≥ 1,500/mm3
- Platelet count ≥ 80,000/mm3, Hemoglobin ≥ 9.0 g/dL
- people must have the ability to understand and the willingness to sign a written informed consent document.
- people must have tumor less than or equal to 5 cm in largest dimension as assessed radiographically.
- Treatment naive for MIBC.
- Presence of hydronephrosis.
- Presence of multifocal disease that is not amenable to complete resection with partial cystectomy.
- Presence of distant carcinoma in situ.
- Presence of clinical N+ or M+ disease.
- Presence of cT4+ disease.
- Non-urothelial histology.
- Concurrent upper tract (ureter or renal pelvis) or urethral urothelial carcinoma.
- people who are not surgical candidates due to competing medical comorbidities or who refuse surgical treatment.
- Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the...
The study team makes the final eligibility decision.
Where it's taking place
- Cleveland, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cleveland, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.