Malignant Neoplasm of BladderPhase 2NCT06290687
Partial Cystectomy & Extended Pelvic Lymph Node Dissection With SOC Perioperative Systemic Therapy
A Phase 2 study testing Neoadjuvant Chemotherapy, Partial cystectomy with Extended pelvic lymph node dissection and Adjuvant systemic therapy in people with Malignant Neoplasm of Bladder and Muscle Invasive Bladder Carcinoma, run by Case Comprehensive Cancer Center.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Malignant Neoplasm of Bladder, Muscle Invasive Bladder Carcinoma
- What is being tested?
- Neoadjuvant Chemotherapy, Partial cystectomy with Extended pelvic lymph node dissection and Adjuvant systemic therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to 29 Dec 2027
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects 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.
- Subjects 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 efficacy in subjects 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.
- Subjects must have normal organ and marrow function as defined below:
- Total bilirubin within normal limits
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- 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
- Subjects must have the ability to understand and the willingness to sign a written informed consent document.
- Subjects must have tumor less than or equal to 5 cm in largest dimension as assessed radiographically.
- Treatment naive for MIBC.
Who cannot join
- 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.
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- Concurrent upper tract (ureter or renal pelvis) or urethral urothelial carcinoma.
- Subjects 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 protocol-specified assessments.
About this study
Official title: Phase II Trial on the Safety and Efficacy of Partial Cystectomy and Extended Pelvic Lymph Node Dissection With Standard of Care Perioperative Systemic Therapy in the Management of Muscle-Invasive Bladder Cancer (PRESERVE 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.
Read the detailed description
Radical cystectomy (surgical removal of the bladder) with pelvic lymph node dissection and urinary diversion, with neoadjuvant chemotherapy in eligible participants, is the standard of care in participants with muscle-invasive bladder cancer (MIBC). While this has demonstrated efficacy in the treatment of MIBC, it has risk of perioperative morbidity and impacts quality of life. Partial cystectomy (surgical removal of a portion of the bladder) is one option for bladder-sparing treatment of select bladder cancer participants and is included in the National Comprehensive Cancer Network bladder cancer treatment guidelines. This treatment has the advantage of less invasive treatment with a lower risk of surgical complication and better health-related quality of life (HRQOL) while providing pathologic staging, however there are limited data on outcomes with this treatment, especially patient-reported HRQOL outcomes. Additionally, much of the existing literature on efficacy of this treatment predates the use of advanced imaging in preoperative staging and advances in surgical technique including use of minimally-invasive surgical approaches and enhanced-recovery post-operative care paths. Given these limitations in the existing literature, the aim of this clinical trial is to examine the safety and efficacy and HRQOL outcomes of partial cystectomy with extended pelvic lymph node dissection, with standard of care perioperative systemic therapy in eligible participants.
- Being tested
- Neoadjuvant Chemotherapy, Partial cystectomy with Extended pelvic lymph node dissection, Adjuvant systemic therapy
- Keywords
- Partial cystectomy, Pelvic Lymph Node Dissection
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant ChemotherapyDrug
Standard of care neoadjuvant systemic therapy is currently cisplatin-based chemotherapy in cisplatin-eligible participants. Participants will start treatment within 60 days of Transurethral Resection of Bladder Tumor. Regimens may include:
- Cisplatin - Gemcitabine (Gem/Cis)
- Dose Dense Methotrexate - Vinblastine - Adriamycin - Cisplatin (MVAC)
Partial cystectomy with Extended pelvic lymph node dissectionProcedure or surgery
Partial cystectomy will then be performed using the surgical technique at the discretion of the treating Urologic Oncologist. Extended pelvic lymphadenectomy will then be performed at the discretion of the treating Urologic Oncologist. Surgery will be performed within 60 days of Transurethral Resection of Bladder Tumor for Cisplatin-ineligible participants. Surgery will be performed within 60 days of completing neoadjuvant chemotherapy for Cisplatin-eligible participants.
Adjuvant systemic therapyDrug
Standard of care adjuvant systemic therapy in eligible participants. The choice of adjuvant systemic therapy will be left to the discretion of the treating Medical Oncologist but must fall within the SOC as outlined in NCCN guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Cisplatin Eligible Participants | Experimental | 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 Receives: Drug: Neoadjuvant Chemotherapy; Procedure: Partial cystectomy with Extended pelvic lymph node dissection; Drug: Adjuvant systemic therapy |
| Cisplatin Ineligible Participants | Experimental | 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 Receives: Procedure: Partial cystectomy with Extended pelvic lymph node dissection; Drug: Adjuvant systemic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-Free Survival (RFS)
Recurrence-Free Survival (RFS) is defined as the time from post-surgery baseline scan (revealing no recurrent/metastatic disease) until the first occurrence of either local or distant recurrence as assessed by CT or MRI and/or biopsy. The primary outcome of distant RFS will be assessed via Kaplan-Meier analysis
Measured: Up to 24 months from date of post-surgery baseline scan
Secondary outcomes (6)
Presence of Post-operative Complications
The Clavien-Dindo classification will measure post-operative complications. The Clavien-Dindo Classification of Post-operative Complications is a tool to assess complications following surgical treatment. This tool ranks complications on a scale of seven levels, with level 1 being the least complicated and 7 being the worst complication resulting in death. The average classification at 90 days will be assessed and reported.
Measured: At 90 days after surgery
Median Bladder RFS
The median duration of bladder recurrence-free survival at 2 years.
Measured: Up to 24 months from date of post-surgery baseline scan
Median Muscle-Invasive Bladder RFS
The median duration of muscle-invasive bladder recurrence-free survival at 2 years.
Measured: Up to 24 months from date of post-surgery baseline scan
Median Bladder-Intact Survival
The median duration of bladder-intact survival at 2 years.
Measured: Up to 24 months from date of post-surgery baseline scan
Median Cancer-Specific Survival
The median duration of cancer-specific survival at 2 years.
Measured: Up to 24 months from date of post-surgery baseline scan
Changes in Genitourinary-specific HRQoL
The mean changes in Genitourinary-specific HRQoL will be reported. The HRQoL survey is composed of five functional scales (physical, role, emotional, cognitive, and social functioning), three symptom scales (fatigue, nausea and vomiting, pain), a global health status/QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The scales and single-item measures range from 0 - 100, with higher values representing a higher response level.
Measured: Up to 24 months from date of post-surgery baseline scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study startSep 2026 (estimated)
- Primary completion29 Dec 2026 (estimated)
- Study completion29 Dec 2027 (estimated)
Why it stopped: PI left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Neoplasm of BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a single-center, prospective, phase II trial.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nima Almassi, MD, Principal investigator, Cleveland Clinic, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06290687
- Sponsor's protocol ID
- CASE5824
- Status last verified
- Sep 2026
- First submitted
- 26 Feb 2024
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial on the Safety and Efficacy of Partial Cystectomy and Extended Pelvic Lymph Node Dissection With Standard of Care Perioperative Systemic Therapy in the Management of Muscle-Invasive Bladder Cancer (PRESERVE Trial)
- ClinicalTrials.gov ID
- NCT06290687
- Acronym / sponsor ID
- CASE5824
- Keywords
- Partial cystectomy, Pelvic Lymph Node Dissection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI left institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- 29 Dec 2026 (estimated)
- Study completion
- 29 Dec 2027 (estimated)
- First posted
- 4 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Radical cystectomy (surgical removal of the bladder) with pelvic lymph node dissection and urinary diversion, with neoadjuvant chemotherapy in eligible participants, is the standard of care in participants with muscle-invasive bladder cancer (MIBC). While this has demonstrated efficacy in the treatment of MIBC, it has risk of perioperative morbidity and impacts quality of life. Partial cystectomy (surgical removal of a portion of the bladder) is one option for bladder-sparing treatment of select bladder cancer participants and is included in the National Comprehensive Cancer Network bladder cancer treatment guidelines. This treatment has the advantage of less invasive treatment with a lower risk of surgical complication and better health-related quality of life (HRQOL) while providing pathologic staging, however there are limited data on outcomes with this treatment, especially patient-reported HRQOL outcomes. Additionally, much of the existing literature on efficacy of this treatment predates the use of advanced imaging in preoperative staging and advances in surgical technique including use of minimally-invasive surgical approaches and enhanced-recovery post-operative care paths. Given these limitations in the existing literature, the aim of this clinical trial is to examine the safety and efficacy and HRQOL outcomes of partial cystectomy with extended pelvic lymph node dissection, with standard of care perioperative systemic therapy in eligible participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a single-center, prospective, phase II trial.
| Arm | Type | Receives |
|---|---|---|
| Cisplatin Eligible Participants | Experimental | Drug: Neoadjuvant Chemotherapy, Procedure: Partial cystectomy with Extended pelvic lymph node dissection, Drug: Adjuvant systemic therapyParticipants 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 |
| Cisplatin Ineligible Participants | Experimental | Procedure: Partial cystectomy with Extended pelvic lymph node dissection, Drug: Adjuvant systemic therapyParticipants 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 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Subjects 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.
- Subjects 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 efficacy in subjects 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.
- Subjects must have normal organ and marrow function as defined below:
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neoadjuvant ChemotherapyStandard of care neoadjuvant systemic therapy is currently cisplatin-based chemotherapy in cisplatin-eligible participants. Participants will start treatment within 60 days of Transurethral Resection of Bladder Tumor. Regimens may include: * Cisplatin - Gemcitabine (Gem/Cis) * Dose Dense Methotrexate - Vinblastine - Adriamycin - Cisplatin (MVAC) | Drug | Cisplatin Eligible Participants |
| Partial cystectomy with Extended pelvic lymph node dissectionPartial cystectomy will then be performed using the surgical technique at the discretion of the treating Urologic Oncologist. Extended pelvic lymphadenectomy will then be performed at the discretion of the treating Urologic Oncologist. Surgery will be performed within 60 days of Transurethral Resection of Bladder Tumor for Cisplatin-ineligible participants. Surgery will be performed within 60 days of completing neoadjuvant chemotherapy for Cisplatin-eligible participants. | Procedure or surgery | Cisplatin Eligible Participants, Cisplatin Ineligible Participants |
| Adjuvant systemic therapyStandard of care adjuvant systemic therapy in eligible participants. The choice of adjuvant systemic therapy will be left to the discretion of the treating Medical Oncologist but must fall within the SOC as outlined in NCCN guidelines. | Drug | Cisplatin Eligible Participants, Cisplatin Ineligible Participants |
Primary outcome
Recurrence-Free Survival (RFS)
Time frame: Up to 24 months from date of post-surgery baseline scan
Recurrence-Free Survival (RFS) is defined as the time from post-surgery baseline scan (revealing no recurrent/metastatic disease) until the first occurrence of either local or distant recurrence as assessed by CT or MRI and/or biopsy. The primary outcome of distant RFS will be assessed via Kaplan-Meier analysis
6 secondary outcomes
Presence of Post-operative Complications
Time frame: At 90 days after surgery
Median Bladder RFS
Time frame: Up to 24 months from date of post-surgery baseline scan
Median Muscle-Invasive Bladder RFS
Time frame: Up to 24 months from date of post-surgery baseline scan
Median Bladder-Intact Survival
Time frame: Up to 24 months from date of post-surgery baseline scan
Median Cancer-Specific Survival
Time frame: Up to 24 months from date of post-surgery baseline scan
Changes in Genitourinary-specific HRQoL
Time frame: Up to 24 months from date of post-surgery baseline scan
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nima Almassi, MD principal investigator
Cleveland Clinic, Case Comprehensive Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Neoadjuvant Chemotherapy, Partial cystectomy with Extended pelvic lymph node dissection and Adjuvant systemic therapy in people with Malignant Neoplasm of Bladder and Muscle Invasive Bladder Carcinoma, run by Case Comprehensive Cancer Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence-Free Survival (RFS) (time frame: Up to 24 months from date of post-surgery baseline scan). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.