Partial Cystectomy for Bladder Cancer

Overseen By Nima Almassi, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Case Comprehensive Cancer Center

Disqualifiers: Hydronephrosis, Distant carcinoma, Non-urothelial histology, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

40 Participants Needed

Trial Summary

What is the purpose of this trial?

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. Participants will receive the standard pre-surgery treatment for approximately 4 to 6 weeks. After the pre-surgery treatment is completed, participants will undergo a partial cystectomy with extended pelvic lymph node dissection. After surgery, participants will receive adjuvant systemic therapy.

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.

What data supports the effectiveness of the treatment Partial Cystectomy for Bladder Cancer?

Research shows that using neoadjuvant chemotherapy (treatment given before surgery) for muscle-invasive bladder cancer can improve survival rates compared to surgery alone. This approach helps eliminate small, hidden cancer cells and can lead to better outcomes, including the possibility of preserving the bladder in some cases. ^{1 2 3 4 5}

Is partial cystectomy with neoadjuvant chemotherapy safe for bladder cancer?

Neoadjuvant chemotherapy, used before surgery for muscle-invasive bladder cancer, has been studied for its safety. Some studies report concerns about its toxicity (side effects), which can affect the timing and recovery from surgery, but it is generally considered safe when managed properly. ^{2 4 6 7 8}

How is the treatment of neoadjuvant chemotherapy and partial cystectomy with extended pelvic lymph node dissection unique for bladder cancer?

This treatment is unique because it combines preoperative chemotherapy to shrink the tumor and potentially eradicate hidden cancer cells, with a partial removal of the bladder and extensive lymph node dissection, aiming to preserve bladder function in selected cases while addressing cancer spread. ^{1 2 3 5 9}

Research Team

Nima Almassi, MD

Principal Investigator

Cleveland Clinic, Case Comprehensive Cancer Center

Eligibility Criteria

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

Subjects must have the ability to understand and the willingness to sign a written informed consent document

My bladder cancer is confirmed and is at a specific stage without spread to lymph nodes or other parts.

My bladder cancer can be fully removed with surgery, as my doctor agrees.

Exclusion Criteria

My cancer has spread to lymph nodes or other parts of my body.

I have swelling of a kidney due to urine buildup.

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 protocol-specified assessments

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-surgery Treatment

Participants receive standard pre-surgery treatment, which includes neoadjuvant systemic therapy for approximately 4 to 6 weeks

4-6 weeks

Surgery

Participants undergo partial cystectomy with extended pelvic lymph node dissection

1 week

1 visit (in-person)

Post-surgery Treatment

Participants receive standard of care adjuvant systemic therapy

Varies

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of post-operative complications and recurrence-free survival

24 months

Treatment Details

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.

Participant Groups

Group I: Cisplatin Ineligible Participants Experimental Treatment 2 Interventions

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

Group II: Cisplatin Eligible Participants Experimental Treatment 3 Interventions

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:

Approved in European Union as Neoadjuvant Chemotherapy for:

• Breast cancer
• Ovarian cancer
• Colorectal cancer
• Lung cancer
• Esophageal cancer

Approved in United States as Neoadjuvant Chemotherapy for:

• Breast cancer
• Ovarian cancer
• Colorectal cancer
• Lung cancer
• Esophageal cancer
• Stomach cancer

Approved in Canada as Neoadjuvant Chemotherapy for:

• Breast cancer
• Ovarian cancer
• Colorectal cancer
• Lung cancer
• Esophageal cancer

Approved in Japan as Neoadjuvant Chemotherapy for:

• Breast cancer
• Ovarian cancer
• Colorectal cancer
• Lung cancer
• Esophageal cancer
• Stomach cancer

Approved in China as Neoadjuvant Chemotherapy for:

• Breast cancer
• Ovarian cancer
• Colorectal cancer
• Lung cancer
• Esophageal cancer
• Stomach cancer

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials

472

Recruited

33,400+

Findings from Research

In a study of 43 patients with muscle-invasive bladder cancer, 78% achieved a complete response after neoadjuvant chemotherapy followed by concurrent chemoradiation, indicating a high efficacy of this treatment approach.

The treatment was well-tolerated, with a median overall survival of 61% at 36 months, and 56.1% of patients retained their bladders without disease, highlighting the potential for bladder preservation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bladder preservation by neoadjuvant chemotherapy followed by concurrent chemoradiation for muscle-invasive bladder cancer: experience at Sindh Institute of Urology & Transplantation (SIUT). Tunio, MA., Hashmi, A., Rafi, M., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Optimal Timing of Chemotherapy and Surgery in Patients with Muscle-Invasive Bladder Cancer and Upper Urinary Tract Urothelial Carcinoma. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Neoadjuvant Therapy Using Checkpoint Inhibitors before Radical Cystectomy for Muscle Invasive Bladder Cancer: A Systematic Review. [2021]

3. Japan pubmed.ncbi.nlm.nih.gov

[Neoadjuvant chemotherapy for invasive bladder cancer]. [2013]

4. Greece pubmed.ncbi.nlm.nih.gov

Neoadjuvant Chemotherapy for Patients with Muscle-invasive Urothelial Bladder Cancer Candidates for Curative Surgery: A Prospective Clinical Trial Based on Cisplatin Feasibility. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Optimal timing of chemotherapy and cystectomy. [2021]

6. France pubmed.ncbi.nlm.nih.gov

[Impact of neoadjuvant chemotherapy on therapeutic management of muscle-invasive bladder cancer]. [2015]

7. Pakistan pubmed.ncbi.nlm.nih.gov

Bladder preservation by neoadjuvant chemotherapy followed by concurrent chemoradiation for muscle-invasive bladder cancer: experience at Sindh Institute of Urology & Transplantation (SIUT). [2022]

8. France pubmed.ncbi.nlm.nih.gov

[Neoadjuvant chemotherapy in muscular invasive bladder cancer: Complications and consequences with cystectomy]. [2015]

9. United States pubmed.ncbi.nlm.nih.gov

The Promise and Disappointment of Neoadjuvant Chemotherapy and Transurethral Resection for Muscle Invasive Bladder Cancer: Updated Results and Long-Term Followup. [2023]