Muscle-Invasive Bladder CarcinomaPhase 3NCT05776758
Role of NAC in cT0 Muscle-invasive Bladder Cancer After Maximal TURBt
A Phase 3 study testing cisplatin based neoadjuvant chemotherapy and Radical cystectomy alone in people with Muscle-Invasive Bladder Carcinoma and Chemotherapy Effect, run by Regina Elena Cancer Institute at 1 site in Italy.
Trial summary
This prospective randomized controlled trial (RCT) is designed to provide high level evidence describing the non-inferiority of radical cystectomy (RC) alone versus neoadjuvant chemotherapy (NAC) plus RC on survival outcomes of patients with a diagnostic transurethral resection of bladder tumor (TURBt) of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscle-Invasive Bladder Carcinoma, Chemotherapy Effect, Surgery
- What is being tested?
- cisplatin based neoadjuvant chemotherapy and Radical cystectomy alone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 1 siteItaly
- Study dates
- 13 Aug 2026to Jan 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnostic TURBt with cT2-4, cN0, cM0;
- non-radiologic or endoscopic residual tumor after a maximal TURBt (cT0);
- patients eligible to curative intent, candidate to surgical treatment and/or NAC (all patients must meet all the criteria required to be able to undergo RC and/or NAC);
- ≥ 18 yrs old;
- compliants patients able to follow the study protocol and fill in EORTC quality of life questionnaires;
- patients able to provide a written informed consent for the trial
Who cannot join
- anaesthesiologic contraindications to surgery;
- palliative intent;
- patients ineligible for cisplatin-combination chemotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neoadjuvant Chemotherapy Plus Cystectomy vs Cystectomy Alone for cT0 Muscle-invasive Bladder Cancer After Maximal TURBt: Multicentre Prospective Randomized Controlled Trial
This prospective randomized controlled trial (RCT) is designed to provide high level evidence describing the non-inferiority of radical cystectomy (RC) alone versus neoadjuvant chemotherapy (NAC) plus RC on survival outcomes of patients with a diagnostic transurethral resection of bladder tumor (TURBt) of non-metastatic muscle invasive bladder cancer (MIBC) (T2-T4 N0 M0) and non-radiologic or endoscopic residual tumor after a maximal TURBt (cT0). Our hypothesis is that performing NAC in the absence of residual disease, after a maximal TURBt, has no survival benefit over performing an early cystectomy. Since no downstaging could be achieved in patients with no residual tumor into the bladder, the benefits of neoadjuvant chemotherapy in this setting could be not significant and it might turn into unnecessary toxicity and a substantial delay to surgical treatment.
Read the detailed description
Radical Cystectomy (RC) is considered the reference option for treatment of urothelial muscle invasive bladder cancer (MIBC). However, RC alone has been reported 5-year survival in about 50% of patients. Therefore, to improve survival outcomes in patients with non-metastatic MIBC, cisplatin-based neoadjuvant chemotherapy (NAC) has been introduced. On the one hand, major tolerability, higher patient compliance and lower burden of micrometastatic disease are listed as potential advantages of administering NAC before planned definitive surgery. Several phase III randomized controlled trials (RCTs) reported the potential survival benefit of NAC administration.
Moreover, the updated analysis of a large phase III RCT, globally including all patients with muscle invasive bladder cancer from T2 to T4, regardless of post transurethral resection of bladder tumor (TURBt) tumor volume, with a median follow-up of 8-yrs confirmed previous results providing additional findings:
- 16% reduction in mortality risk;
- improvement in 10-yr survival from 30% to 36% with NAC;
- Benefit with regard to distant metastases;
- the addition of NAC provided no benefit for locoregional control and locoregional disease free survival (DFS).
On the other hand, the possibility to predict patients' sensitivity to chemotherapy is still limited. Therefore, the delay in performing RC and the theoretical impact of NAC on surgical morbidity are considered significant limitations to a routine administration of neoadjuvant treatments. As a result, it is growing the interest at improving selection clinical criteria to identify the ideal candidates to NAC, in order to obtain the maximal survival benefit of NAC, minimizing its possible disadvantages. Reliable predictive markers and molecular tumour profiling might guide the use of NAC in the future, but nowadays they are not currently used in clinical practice.
Despite the evidence supporting the use of NAC, its routine administration is still limited. The risk of unresponse after NAC, with the consequent delay in surgical treatment, and the possible impact on surgical morbidity after RC, are the major limitations to the wide administration of NAC. Previous evidences supported the use of NAC in patients with T2 to T4a BCa, regardless of tumor volume at the time of NAC. It is growing the interest on a tailored approach to treat genitourinary cancer, therefore it is needed much more efforts to select which patient will benefit most from NAC rather than an early RC. To answer this question, it is needed to selectively perform RCTs aiming to test specific treatments in equally specific patients. The primary objective of the trial is to demonstrate the non-inferiority of RC alone versus NAC plus RC on survival outcomes of patients with a diagnostic TURBt of non-metastatic muscle invasive bladder cancer (MIBC) (T2-T4 N0 M0) and non-radiologic or endoscopic residual tumor after a maximal TURBt (cT0). Survival benefits of cisplatin-based NAC were already described. The SWOG trial 3 reported a 33% reduction of estimated risk of death in the NAC plus cystectomy group compared to RC alone.
Specifically, Authors reported that survival benefit of NAC appeared to be strongly related to downstaging of the tumor to pT0: 38% and 15% in NAC plus RC and RC alone cohorts, respectively (p<0.001). At 5yr, 85% of the patients with a pT0 surgical specimen were alive. Analysis of survival according to treatment group (NAC plus cystectomy vs cystectomy alone) and pathologically free of cancer (pT0) or residual disease at the time of cystectomy evidenced comparable outcomes between groups in pT0 patients (2yr OS: 90% vs 94% in NAC plus RC and RC alone cohorts, respectively) while a slight difference occurred in patients with residual disease at the time of cystectomy (2yr OS: 66% vs 52% in NAC plus RC and RC alone cohorts, respectively). As a result, the impact of NAC seems to play a negligible role in pT0 patients, while major benefits were observed in presence of residual disease. However, all the available RCTs did not discuss the endoscopically feasibility to achieve a cT0 stage, after a maximal TURBt, prior to RC. Moreover, systematic therapies are not devoid of limitations and they need to be carefully administered, in order to reduce toxicity, to minimize the risk of cystectomy delay in patients not sensitive to chemotherapy and to reduce the impact of NAC on surgical and health related quality of life (HRQoL) outcomes. Therefore, it is necessary to improve the selection criteria of patients' candidates for NAC plus cystectomy.
The hypothesis of investigators is that performing NAC in the absence of residual disease, after a maximal TURBt, has no survival benefit over performing an early cystectomy. Whenever endoscopically feasible, the complete resection of MIBC during TURB, particularly for T2 bladder cancer, will define a condition of cT0 stage, where probably no benefits would be observed in terms of downstaging for patients receiving NAC plus RC than those undergoing an early RC alone.
- Being tested
- cisplatin based neoadjuvant chemotherapy, Radical cystectomy alone
- Keywords
- Bladder cancer, Muscle-invasive bladder cancer, Radical cystectomy, Survival outcomes
- 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.
cisplatin based neoadjuvant chemotherapyDrug
cisplatin based neoadjuvant chemotherapy
Radical cystectomy aloneProcedure or surgery
RC alone
| Study group | Role | What they receive |
|---|---|---|
| NAC+RC | Experimental | cisplatin-based neoadjuvant chemotherapy plus radical cystectomy Receives: Drug: cisplatin based neoadjuvant chemotherapy; Procedure: Radical cystectomy alone |
| RC alone | Active comparator | radical cystectomy alone Receives: Procedure: Radical cystectomy alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate the non-inferiority of radical cystectomy (RC) alone versus neoadjuvant chemotherapy plus RC on 2 years Overall Survival (OS) rates, defined as the length of time from surgery until death from any cause.
Overall Survival rates
Measured: 2 years
Secondary outcomes (7)
To compare disease free survival (DFS) rates, defined as the length of time from surgery to local disease recurrence
To evaluate early (6 months), mid-term (1 year) and long-term (2 years) DFS rates
Measured: 6 months, 1 year, 2 years
To evaluate metastasis free survival (MFS) rates, defined as the length of time from surgery to metastasis recurrence.
To evaluate early (6 months), mid-term (1 year) and long-term (2 years) MFS rates
Measured: 6 months, 1 year, 2 years
To evaluate recurrence free survival (RFS), rates defined as the length of time from surgery to disease recurrence.
To evaluate early (6 months), mid-term (1 year) and long-term (2 years) RFS rates
Measured: 6 months, 1 year, 2 years
To evaluate impact of NAC on perioperative complications rate (described accordingly to Clavien Dindo classification into minor o major complications)
To evaluate impact of NAC on perioperative complications rate within hospital stay
Measured: Within hospital stay
To evaluate impact of NAC on postoperative complications rate described accordingly to Clavien Dindo classification into minor o major complications)
To evaluate impact of NAC on postoperative complications rate at 30 days, 90 days and 180 days
Measured: 30 days, 90 days and 180 days
To evaluate impact of NAC on readmission rates (defined as postoperative rehospitalization)
To evaluate impact of NAC on readmission rates at 30 days, 90 days and 180 days
Measured: 30 days, 90 days and 180 days
To compare health-related quality of life (HRQoL) outcomes, using EORTC self-assessed questionnaires
To compare health-related quality of life (HRQoL) outcomes at 3 months, 6 months, 1 year and 2 years
Measured: 3 months, 6 months, 1 year and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start13 Aug 2026
- Primary completionJan 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Muscle-Invasive Bladder CarcinomaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 236 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regina Elena Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe SImone, Regina Elena Cancer Institute
- Investigators
- Giuseppe Simone, MD, Principal investigator, IRCCS "Regina Elena" National Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05776758
- Sponsor's protocol ID
- RS1779/22(2738)
- Status last verified
- Aug 2026
- First submitted
- 31 Jan 2023
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stein JP, Lieskovsky G, Cote R, Groshen S, Feng AC, Boyd S, Skinner E, Bochner B, Thangathurai D, Mikhail M, Raghavan D, Skinner DG. Radical cystectomy in the treatment of invasive bladder cancer: long-term results in 1,054 patients. J Clin Oncol. 2001 Feb 1;19(3):666-75. doi: 10.1200/JCO.2001.19.3.666.
PubMed 11157016Stein JP, Skinner DG. Radical cystectomy for invasive bladder cancer: long-term results of a standard procedure. World J Urol. 2006 Aug;24(3):296-304. doi: 10.1007/s00345-006-0061-7. Epub 2006 Mar 4.
PubMed 16518661Grossman HB, Natale RB, Tangen CM, Speights VO, Vogelzang NJ, Trump DL, deVere White RW, Sarosdy MF, Wood DP Jr, Raghavan D, Crawford ED. Neoadjuvant chemotherapy plus cystectomy compared with cystectomy alone for locally advanced bladder cancer. N Engl J Med. 2003 Aug 28;349(9):859-66. doi: 10.1056/NEJMoa022148.
PubMed 12944571Neoadjuvant cisplatin, methotrexate, and vinblastine chemotherapy for muscle-invasive bladder cancer: a randomised controlled trial. International collaboration of trialists. Lancet. 1999 Aug 14;354(9178):533-40.
PubMed 10470696International Collaboration of Trialists; Medical Research Council Advanced Bladder Cancer Working Party (now the National Cancer Research Institute Bladder Cancer Clinical Studies Group); European Organisation for Research and Treatment of Cancer Genito-Urinary Tract Cancer Group; Australian Bladder Cancer Study Group; National Cancer Institute of Canada Clinical Trials Group; Finnbladder; Norwegian Bladder Cancer Study Group; Club Urologico Espanol de Tratamiento Oncologico Group; Griffiths G, Hall R, Sylvester R, Raghavan D, Parmar MK. International phase III trial assessing neoadjuvant cisplatin, methotrexate, and vinblastine chemotherapy for muscle-invasive bladder cancer: long-term results of the BA06 30894 trial. J Clin Oncol. 2011 Jun 1;29(16):2171-7. doi: 10.1200/JCO.2010.32.3139. Epub 2011 Apr 18.
PubMed 21502557Takata R, Katagiri T, Kanehira M, Tsunoda T, Shuin T, Miki T, Namiki M, Kohri K, Matsushita Y, Fujioka T, Nakamura Y. Predicting response to methotrexate, vinblastine, doxorubicin, and cisplatin neoadjuvant chemotherapy for bladder cancers through genome-wide gene expression profiling. Clin Cancer Res. 2005 Apr 1;11(7):2625-36. doi: 10.1158/1078-0432.CCR-04-1988.
PubMed 15814643Takata R, Katagiri T, Kanehira M, Shuin T, Miki T, Namiki M, Kohri K, Tsunoda T, Fujioka T, Nakamura Y. Validation study of the prediction system for clinical response of M-VAC neoadjuvant chemotherapy. Cancer Sci. 2007 Jan;98(1):113-7. doi: 10.1111/j.1349-7006.2006.00366.x.
PubMed 17116130Driscoll JJ, Rixe O. Overall survival: still the gold standard: why overall survival remains the definitive end point in cancer clinical trials. Cancer J. 2009 Sep-Oct;15(5):401-5. doi: 10.1097/PPO.0b013e3181bdc2e0.
PubMed 19826360Kim HS, Jeong CW, Kwak C, Kim HH, Ku JH. Disease-Free Survival at 2 and 3 Years is a Significant Early Surrogate Marker Predicting the 5-Year Overall Survival in Patients Treated with Radical Cystectomy for Urothelial Carcinoma of the Bladder: External Evaluation and Validation in a Cohort of Korean Patients. Front Oncol. 2015 Oct 29;5:246. doi: 10.3389/fonc.2015.00246. eCollection 2015.
PubMed 26579498Witjes JA, Bruins HM, Cathomas R, Comperat EM, Cowan NC, Gakis G, Hernandez V, Linares Espinos E, Lorch A, Neuzillet Y, Rouanne M, Thalmann GN, Veskimae E, Ribal MJ, van der Heijden AG. European Association of Urology Guidelines on Muscle-invasive and Metastatic Bladder Cancer: Summary of the 2020 Guidelines. Eur Urol. 2021 Jan;79(1):82-104. doi: 10.1016/j.eururo.2020.03.055. Epub 2020 Apr 29.
PubMed 32360052Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
PubMed 15273542
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Chemotherapy Plus Cystectomy vs Cystectomy Alone for cT0 Muscle-invasive Bladder Cancer After Maximal TURBt: Multicentre Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05776758
- Acronym / sponsor ID
- RS1779/22(2738)
- Keywords
- Bladder cancer, Muscle-invasive bladder cancer, Radical cystectomy, Survival outcomes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 236 participants (estimated)
- Lead sponsor
- Regina Elena Cancer InstituteUniversity, hospital or other
- Study start
- 13 Aug 2026 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 20 Mar 2023 (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.
This prospective randomized controlled trial (RCT) is designed to provide high level evidence describing the non-inferiority of radical cystectomy (RC) alone versus neoadjuvant chemotherapy (NAC) plus RC on survival outcomes of patients with a diagnostic transurethral resection of bladder tumor (TURBt) of non-metastatic muscle invasive bladder cancer (MIBC) (T2-T4 N0 M0) and non-radiologic or endoscopic residual tumor after a maximal TURBt (cT0). Our hypothesis is that performing NAC in the absence of residual disease, after a maximal TURBt, has no survival benefit over performing an early cystectomy. Since no downstaging could be achieved in patients with no residual tumor into the bladder, the benefits of neoadjuvant chemotherapy in this setting could be not significant and it might turn into unnecessary toxicity and a substantial delay to surgical treatment.
Detailed description
Radical Cystectomy (RC) is considered the reference option for treatment of urothelial muscle invasive bladder cancer (MIBC). However, RC alone has been reported 5-year survival in about 50% of patients. Therefore, to improve survival outcomes in patients with non-metastatic MIBC, cisplatin-based neoadjuvant chemotherapy (NAC) has been introduced. On the one hand, major tolerability, higher patient compliance and lower burden of micrometastatic disease are listed as potential advantages of administering NAC before planned definitive surgery. Several phase III randomized controlled trials (RCTs) reported the potential survival benefit of NAC administration.
Moreover, the updated analysis of a large phase III RCT, globally including all patients with muscle invasive bladder cancer from T2 to T4, regardless of post transurethral resection of bladder tumor (TURBt) tumor volume, with a median follow-up of 8-yrs confirmed previous results providing additional findings:
- 16% reduction in mortality risk;
- improvement in 10-yr survival from 30% to 36% with NAC;
- Benefit with regard to distant metastases;
- the addition of NAC provided no benefit for locoregional control and locoregional disease free survival (DFS).
On the other hand, the possibility to predict patients' sensitivity to chemotherapy is still limited. Therefore, the delay in performing RC and the theoretical impact of NAC on surgical morbidity are considered significant limitations to a routine administration of neoadjuvant treatments. As a result, it is growing the interest at improving selection clinical criteria to identify the ideal candidates to NAC, in order to obtain the maximal survival benefit of NAC, minimizing its possible disadvantages. Reliable predictive markers and molecular tumour profiling might guide the use of NAC in the future, but nowadays they are not currently used in clinical practice.
Despite the evidence supporting the use of NAC, its routine administration is still limited. The risk of unresponse after NAC, with the consequent delay in surgical treatment, and the possible impact on surgical morbidity after RC, are the major limitations to the wide administration of NAC. Previous evidences supported the use of NAC in patients with T2 to T4a BCa, regardless of tumor volume at the time of NAC. It is growing the interest on a tailored approach to treat genitourinary cancer, therefore it is needed much more efforts to select which patient will benefit most from NAC rather than an early RC. To answer this question, it is needed to selectively perform RCTs aiming to test specific treatments in equally specific patients. The primary objective of the trial is to demonstrate the non-inferiority of RC alone versus NAC plus RC on survival outcomes of patients with a diagnostic TURBt of non-metastatic muscle invasive bladder cancer (MIBC) (T2-T4 N0 M0) and non-radiologic or endoscopic residual tumor after a maximal TURBt (cT0). Survival benefits of cisplatin-based NAC were already described. The SWOG trial 3 reported a 33% reduction of estimated risk of death in the NAC plus cystectomy group compared to RC alone.
Specifically, Authors reported that survival benefit of NAC appeared to be strongly related to downstaging of the tumor to pT0: 38% and 15% in NAC plus RC and RC alone cohorts, respectively (p<0.001). At 5yr, 85% of the patients with a pT0 surgical specimen were alive. Analysis of survival according to treatment group (NAC plus cystectomy vs cystectomy alone) and pathologically free of cancer (pT0) or residual disease at the time of cystectomy evidenced comparable outcomes between groups in pT0 patients (2yr OS: 90% vs 94% in NAC plus RC and RC alone cohorts, respectively) while a slight difference occurred in patients with residual disease at the time of cystectomy (2yr OS: 66% vs 52% in NAC plus RC and RC alone cohorts, respectively). As a result, the impact of NAC seems to play a negligible role in pT0 patients, while major benefits were observed in presence of residual disease. However, all the available RCTs did not discuss the endoscopically feasibility to achieve a cT0 stage, after a maximal TURBt, prior to RC. Moreover, systematic therapies are not devoid of limitations and they need to be carefully administered, in order to reduce toxicity, to minimize the risk of cystectomy delay in patients not sensitive to chemotherapy and to reduce the impact of NAC on surgical and health related quality of life (HRQoL) outcomes. Therefore, it is necessary to improve the selection criteria of patients' candidates for NAC plus cystectomy.
The hypothesis of investigators is that performing NAC in the absence of residual disease, after a maximal TURBt, has no survival benefit over performing an early cystectomy. Whenever endoscopically feasible, the complete resection of MIBC during TURB, particularly for T2 bladder cancer, will define a condition of cT0 stage, where probably no benefits would be observed in terms of downstaging for patients receiving NAC plus RC than those undergoing an early RC alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NAC+RC | Experimental | Drug: cisplatin based neoadjuvant chemotherapy, Procedure: Radical cystectomy alonecisplatin-based neoadjuvant chemotherapy plus radical cystectomy |
| RC alone | Active comparator | Procedure: Radical cystectomy aloneradical cystectomy alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- diagnostic TURBt with cT2-4, cN0, cM0;
- non-radiologic or endoscopic residual tumor after a maximal TURBt (cT0);
- patients eligible to curative intent, candidate to surgical treatment and/or NAC (all patients must meet all the criteria required to be able to undergo RC and/or NAC);
- ≥ 18 yrs old;
- compliants patients able to follow the study protocol and fill in EORTC quality of life questionnaires;
Key exclusion criteria (3 listed)
- anaesthesiologic contraindications to surgery;
- palliative intent;
- patients ineligible for cisplatin-combination chemotherapy
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 |
|---|---|---|
| cisplatin based neoadjuvant chemotherapycisplatin based neoadjuvant chemotherapy | Drug | NAC+RC |
| Radical cystectomy aloneRC alone | Procedure or surgery | NAC+RC, RC alone |
Primary outcome
To demonstrate the non-inferiority of radical cystectomy (RC) alone versus neoadjuvant chemotherapy plus RC on 2 years Overall Survival (OS) rates, defined as the length of time from surgery until death from any cause.
Time frame: 2 years
Overall Survival rates
7 secondary outcomes
To compare disease free survival (DFS) rates, defined as the length of time from surgery to local disease recurrence
Time frame: 6 months, 1 year, 2 years
To evaluate metastasis free survival (MFS) rates, defined as the length of time from surgery to metastasis recurrence.
Time frame: 6 months, 1 year, 2 years
To evaluate recurrence free survival (RFS), rates defined as the length of time from surgery to disease recurrence.
Time frame: 6 months, 1 year, 2 years
To evaluate impact of NAC on perioperative complications rate (described accordingly to Clavien Dindo classification into minor o major complications)
Time frame: Within hospital stay
To evaluate impact of NAC on postoperative complications rate described accordingly to Clavien Dindo classification into minor o major complications)
Time frame: 30 days, 90 days and 180 days
To evaluate impact of NAC on readmission rates (defined as postoperative rehospitalization)
Time frame: 30 days, 90 days and 180 days
To compare health-related quality of life (HRQoL) outcomes, using EORTC self-assessed questionnaires
Time frame: 3 months, 6 months, 1 year and 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Results publication: PubMed 11157016Stein JP, Lieskovsky G, Cote R, Groshen S, Feng AC, Boyd S, Skinner E, Bochner B, Thangathurai D, Mikhail M, Raghavan D, Skinner DG. Radical cystectomy in the treatment of invasive bladder cancer: long-term results in 1,054 patients. J Clin Oncol. 2001 Feb 1;19(3):666-75. doi: 10.1200/JCO.2001.19.3.666.
- Results publication: PubMed 16518661Stein JP, Skinner DG. Radical cystectomy for invasive bladder cancer: long-term results of a standard procedure. World J Urol. 2006 Aug;24(3):296-304. doi: 10.1007/s00345-006-0061-7. Epub 2006 Mar 4.
- Results publication: PubMed 12944571Grossman HB, Natale RB, Tangen CM, Speights VO, Vogelzang NJ, Trump DL, deVere White RW, Sarosdy MF, Wood DP Jr, Raghavan D, Crawford ED. Neoadjuvant chemotherapy plus cystectomy compared with cystectomy alone for locally advanced bladder cancer. N Engl J Med. 2003 Aug 28;349(9):859-66. doi: 10.1056/NEJMoa022148.
- Results publication: PubMed 10470696Neoadjuvant cisplatin, methotrexate, and vinblastine chemotherapy for muscle-invasive bladder cancer: a randomised controlled trial. International collaboration of trialists. Lancet. 1999 Aug 14;354(9178):533-40.
- Results publication: PubMed 21502557International Collaboration of Trialists; Medical Research Council Advanced Bladder Cancer Working Party (now the National Cancer Research Institute Bladder Cancer Clinical Studies Group); European Organisation for Research and Treatment of Cancer Genito-Urinary Tract Cancer Group; Australian Bladder Cancer Study Group; National Cancer Institute of Canada Clinical Trials Group; Finnbladder; Norwegian Bladder Cancer Study Group; Club Urologico Espanol de Tratamiento Oncologico Group; Griffiths G, Hall R, Sylvester R, Raghavan D, Parmar MK. International phase III trial assessing neoadjuvant cisplatin, methotrexate, and vinblastine chemotherapy for muscle-invasive bladder cancer: long-term results of the BA06 30894 trial. J Clin Oncol. 2011 Jun 1;29(16):2171-7. doi: 10.1200/JCO.2010.32.3139. Epub 2011 Apr 18.
- Results publication: PubMed 15814643Takata R, Katagiri T, Kanehira M, Tsunoda T, Shuin T, Miki T, Namiki M, Kohri K, Matsushita Y, Fujioka T, Nakamura Y. Predicting response to methotrexate, vinblastine, doxorubicin, and cisplatin neoadjuvant chemotherapy for bladder cancers through genome-wide gene expression profiling. Clin Cancer Res. 2005 Apr 1;11(7):2625-36. doi: 10.1158/1078-0432.CCR-04-1988.
- Results publication: PubMed 17116130Takata R, Katagiri T, Kanehira M, Shuin T, Miki T, Namiki M, Kohri K, Tsunoda T, Fujioka T, Nakamura Y. Validation study of the prediction system for clinical response of M-VAC neoadjuvant chemotherapy. Cancer Sci. 2007 Jan;98(1):113-7. doi: 10.1111/j.1349-7006.2006.00366.x.
- Results publication: PubMed 19826360Driscoll JJ, Rixe O. Overall survival: still the gold standard: why overall survival remains the definitive end point in cancer clinical trials. Cancer J. 2009 Sep-Oct;15(5):401-5. doi: 10.1097/PPO.0b013e3181bdc2e0.
- Results publication: PubMed 26579498Kim HS, Jeong CW, Kwak C, Kim HH, Ku JH. Disease-Free Survival at 2 and 3 Years is a Significant Early Surrogate Marker Predicting the 5-Year Overall Survival in Patients Treated with Radical Cystectomy for Urothelial Carcinoma of the Bladder: External Evaluation and Validation in a Cohort of Korean Patients. Front Oncol. 2015 Oct 29;5:246. doi: 10.3389/fonc.2015.00246. eCollection 2015.
- Results publication: PubMed 32360052Witjes JA, Bruins HM, Cathomas R, Comperat EM, Cowan NC, Gakis G, Hernandez V, Linares Espinos E, Lorch A, Neuzillet Y, Rouanne M, Thalmann GN, Veskimae E, Ribal MJ, van der Heijden AG. European Association of Urology Guidelines on Muscle-invasive and Metastatic Bladder Cancer: Summary of the 2020 Guidelines. Eur Urol. 2021 Jan;79(1):82-104. doi: 10.1016/j.eururo.2020.03.055. Epub 2020 Apr 29.
- Results publication: PubMed 15273542Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
- Individual participant dataSharing planned: No
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Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
RecruitingPhase 1
FORAGER-1: A Study of Vepugratinib (LY3866288; LOXO-435) in Participants With Cancer With a Change in a Gene Called FGFR3
Urinary Bladder Neoplasms, Neoplasm Metastasis
RecruitingObservational study
Mood Alterations in the Patients With Non-Muscle Invasive Bladder Cancer Treated With BCG
Non-Muscle Invasive Bladder Cancer
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.
Giuseppe Simone, MD principal investigator
IRCCS "Regina Elena" National Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing cisplatin based neoadjuvant chemotherapy and Radical cystectomy alone in people with Muscle-Invasive Bladder Carcinoma and Chemotherapy Effect, run by Regina Elena Cancer Institute at 1 site in Italy.
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 6 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
To demonstrate the non-inferiority of radical cystectomy (RC) alone versus neoadjuvant chemotherapy plus RC on 2 years Overall Survival (OS) rates, defined as the length of time from surgery until death from any cause. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05776758, which also lists 11 linked publications.
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 17 Aug 2026.