Partial Cystectomy for Bladder Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment for Muscle-Invasive Bladder Cancer by using a partial cystectomy (removal of part of the bladder) instead of a complete removal, along with extended pelvic lymph node removal. The trial aims to determine the effectiveness and safety of this approach and its impact on patients' quality of life. Participants will first receive standard neoadjuvant chemotherapy (preoperative chemotherapy), followed by surgery, and additional adjuvant systemic therapy if needed. Those with a confirmed bladder cancer diagnosis and a tumor size of 5 cm or smaller may be suitable for this trial. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, since participants must be treatment naive for muscle-invasive bladder cancer, it might be necessary to stop certain cancer treatments before joining the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that neoadjuvant chemotherapy (NAC) is usually well-tolerated by patients with muscle-invasive bladder cancer. Studies have found that patients receiving this treatment before surgery often experience good survival rates. Specifically, survival rates at two and three years were about 83.8% and 79.7%, respectively, with cisplatin-based NAC, suggesting it is a safe option for many, though individual reactions can vary.
Regarding partial cystectomy with extended pelvic lymph node dissection, research indicates that this procedure can be as safe as a complete cystectomy (full bladder removal). Some studies report similar quality of life scores for patients after this surgery, suggesting it is generally safe and might be a less invasive option for treating bladder cancer.
While these treatments are generally considered safe, discussing any potential risks with the healthcare team conducting the trial is important.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for bladder cancer because they offer a more personalized approach compared to the current standard of care. Traditionally, bladder cancer treatments often involve a full removal of the bladder, but this trial focuses on partial cystectomy, which preserves more of the bladder and may maintain better quality of life for patients. Furthermore, the trial includes an extended pelvic lymph node dissection, which could potentially improve cancer control by targeting more affected areas. For those eligible for cisplatin-based chemotherapy, combining it with this surgical approach could enhance the effectiveness of treatment. For those ineligible for cisplatin, the surgical technique alone offers a promising alternative, potentially expanding treatment options for a wider patient population.
What evidence suggests that this trial's treatments could be effective for muscle-invasive bladder cancer?
In this trial, researchers will divide participants into two groups based on their eligibility for cisplatin-based neoadjuvant chemotherapy (NAC). For cisplatin-eligible participants, previous studies have shown that NAC using platinum-based drugs can effectively shrink tumors and improve survival rates. These participants will receive NAC followed by partial cystectomy with extended pelvic lymph node dissection.
For cisplatin-ineligible participants, the trial will focus on partial cystectomy with extended pelvic lymph node dissection without NAC. Studies suggest that surgery removing part of the bladder along with nearby lymph nodes can lead to better survival compared to just removing part of the bladder. This approach also shows promise in preserving the bladder, offering good cancer control while maintaining quality of life. Overall, these treatments aim to provide effective alternatives to more invasive surgeries like completely removing the bladder.36789Who Is on the Research Team?
Nima Almassi, MD
Principal Investigator
Cleveland Clinic, Case Comprehensive Cancer Center
Are You a Good Fit for This Trial?
This trial is for individuals with Muscle-Invasive Bladder Cancer. Participants will undergo standard pre-surgery treatment, followed by a partial cystectomy and lymph node removal. Details on specific inclusion and exclusion criteria are not provided.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-surgery Treatment
Participants receive standard pre-surgery treatment, which includes neoadjuvant systemic therapy for approximately 4 to 6 weeks
Surgery
Participants undergo partial cystectomy with extended pelvic lymph node dissection
Post-surgery Treatment
Participants receive standard of care adjuvant systemic therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of post-operative complications and recurrence-free survival
What Are the Treatments Tested in This Trial?
Interventions
- Adjuvant systemic therapy
- Neoadjuvant Chemotherapy
- Partial cystectomy with Extended pelvic lymph node dissection
Trial Overview
The study tests the effectiveness of partial bladder removal (cystectomy) with extended lymph node dissection compared to complete bladder removal, assessing safety, cancer control, and impact on quality of life.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Participants who are deemed ineligible for cisplatin-based NAC will undergo: * Partial cystectomy with extended pelvic lymph node dissection * Standard of care adjuvant systemic therapy in eligible participants
Participants who are deemed eligible for cisplatin-based NAC will undergo: * Standard of care neoadjuvant systemic therapy (currently cisplatin-based chemotherapy in cisplatin-eligible participants) * Partial cystectomy with extended pelvic lymph node dissection * Standard of care adjuvant systemic therapy in eligible patients
Neoadjuvant Chemotherapy is already approved in European Union, United States, Canada, Japan, China for the following indications:
- Breast cancer
- Ovarian cancer
- Colorectal cancer
- Lung cancer
- Esophageal cancer
- Breast cancer
- Ovarian cancer
- Colorectal cancer
- Lung cancer
- Esophageal cancer
- Stomach cancer
- Breast cancer
- Ovarian cancer
- Colorectal cancer
- Lung cancer
- Esophageal cancer
- Breast cancer
- Ovarian cancer
- Colorectal cancer
- Lung cancer
- Esophageal cancer
- Stomach cancer
- Breast cancer
- Ovarian cancer
- Colorectal cancer
- Lung cancer
- Esophageal cancer
- Stomach cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Case Comprehensive Cancer Center
Lead Sponsor
Published Research Related to This Trial
Citations
Comparative effectiveness of neoadjuvant chemotherapy ...
A pCR after NAC was found in 250 (19.2%) patients with UBC and in 23 (8.3%) patients with UTUC (P < 0.01). A pOR after NAC was found in 523 (40.3%) patients ...
Efficacy of neoadjuvant/induction (NAC) chemotherapy in ...
Our analysis found no survival benefit from adding NAC to CRT in patients with MIBC. However, the quality of the evidence is very low.
Neoadjuvant Chemotherapy for High-risk Localized Upper ...
The pathologic response rate was 63%. Estimated 7-yr disease-free, cancer-specific, and overall survival rates were 60%, 77%, and 72%, ...
Real-world comparison of neoadjuvant ...
Studies have confirmed that platinum-based neoadjuvant chemotherapy (NAC) can effectively downstage tumors and provide survival benefits to ...
Perioperative Durvalumab with Neoadjuvant ...
Perioperative durvalumab with neoadjuvant cisplatin-based chemotherapy followed by radical cystectomy provided a significant event-free survival ...
Influence of Neoadjuvant Chemotherapy on Survival ...
Patients receiving neoadjuvant chemotherapy (NAC) prior to radical cystectomy (RC) typically show better survival outcomes than those undergoing immediate ...
Efficacy and safety analysis of neoadjuvant chemotherapy ...
This study examined the efficacy and safety of neoadjuvant chemotherapy combined with immunotherapy in patients with muscle-invasive bladder cancer (MIBC).
Characteristics, treatment patterns, and clinical outcomes ...
Survival rates (95% CI) at 2 and 3 years were 83.8% (77.8–90.2%) and 79.7% (73–87.1%), respectively. Conclusions: Cisplatin-based NAC was widely ...
“Real-world” outcomes and prognostic indicators among ...
Our study demonstrated a 34% increase in overall neoadjuvant treatment from 2001 to 2013, with cisplatin-based therapy increasing from 40% to 83% of neoadjuvant ...
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