Muscle Invasive Bladder CancerREDEMPTEDNCT07008833
Radical CystEctomy or RaDio-chEMotherapy as Preferred Treatment for invasivE blaDder Cancer
A study testing Radiochemotherapy and Radical cystectomy in people with Muscle Invasive Bladder Cancer, run by Brazilian Clinical Research Institute at 1 site in Brazil.
Trial summary
Your text is mostly clear and well-structured. Here's a slightly polished version for improved clarity and flow: This is a randomized, non-inferiority study comparing radiochemotherapy to radical cystectomy in patients with muscle-invasive bladder cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Muscle Invasive Bladder Cancer
- What is being tested?
- Radiochemotherapy and Radical cystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 336 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2026to Feb 2032
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥ 18 years of age.
- Pure or predominant urothelial carcinoma (including other histologic subtypes, with the exception of small cell carcinoma, as a minority component).
- Performance status of 0 to 1, according to the Eastern Cooperative Oncology Group (ECOG) criteria.
- Life expectancy of ≥ 3 months.
- Histologically confirmed T2, T3, or T4a stage bladder cancer (pure or predominant urothelial carcinoma) cN0 or cN1 or cN2 (if lymph nodes within the surgical and radiation fields and size ≤ 2 cm).
- Patients who are candidates for neoadjuvant cisplatin and have undergone TURBT (preferably maximal) prior to treatment.
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- Adequate bladder function (defined as the ability to store and void urine effectively, without symptoms of dysfunction or incontinence).
- Neutrophil count ≥ 1500/mm³.
- Platelet count ≥ 100,000/mm³.
- Hemoglobin count > 10 g/dL.
- Glomerular filtration rate greater than 40 mL/min.
- Serum bilirubin < 1.5 times the upper limit of the normal reference range and SGOT and SGPT < 1.5 times the upper limit of the normal reference range.
- Absence of comorbidities that contraindicate treatment.
- Capable of giving signed and dated informed consent prior to any mandatory study-specific procedures, sampling, and analyses, which includes compliance with the requirements and restrictions listed in the informed consent form and study protocol.
- For inclusion in i) optional exploratory genetic research and ii) optional biomarker research, patients must meet the following criteria:
- Provide informed consent for genetic research prior to sample collection.
- Provide informed consent for biomarker research prior to sample collection.
- If a patient declines to participate in optional biomarker research, there will be no penalty or loss of benefit to the patient. The patient will not be excluded from other aspects of the study.
Who cannot join
- Presence of multiple primary tumors or multiple foci of carcinoma in situ (CIS) (including in the upper tract) that are not candidates for bladder preservation with radiochemotherapy (definition at the discretion of the investigator).
- Age > 80 years.
- Pure adenocarcinoma or pure squamous carcinoma or pure small cell or large cell neuroendocrine carcinoma, micropapillary, sarcomatoid or nested.
- Metastatic or unresectable disease.
- Sensory neuropathy Grade ≥ 2.
- Hearing impairment Grade ≥ 2.
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- Having a known additional malignancy that has progressed or required active treatment in the last 5 years, except superficial bladder cancer and/or carcinoma in situ, basal cell carcinoma of the skin or carcinoma in situ of the cervix.
- Clinically significant cardiovascular disease - functional class III-IV according to the New York Heart Association (NYHA) Classification of heart failure.
- Patients considered to be at high medical risk due to severe and uncontrolled disease, active or non-malignant systemic disease, and severe or potentially severe infection that may affect response to treatment or increase the risk of adverse events.
- Immunocompromised patients.
- Inflammatory bowel disease.
- Patients with known active hepatitis (i.e., hepatitis B or C).
- Patients receiving any prior systemic chemotherapy in the last 5 years for other tumors and at any time for muscle-invasive bladder cancer.
- Patients who have received prior systemic immunotherapy at any time, either in the setting of non-muscle-invasive bladder cancer or in treatment for other types of cancer.
- Prior pelvic radiotherapy.
- Patients, male or female, who do not agree to use an effective method of contraception throughout treatment and until 6 months after discontinuation of treatment.
- Women who are pregnant or currently breastfeeding. 18. The investigator's judgment that the patient should not participate in the study if the patient is unlikely to comply with the procedures, restrictions, and requirements.
- 19. Prior Randomization to the present study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
Brazilian Clinical Research Institute
São Paulo, São Paulo, 01404100
Lilian Mazza Barbosa, 55 11 59047339, lilian@bcri.org.br
About this study
Official title: Randomized, Non-inferiority Study Comparing Radiochemotherapy Versus Radical Cystectomy in Patients With Muscle-invasive Bladder Cancer
Your text is mostly clear and well-structured. Here's a slightly polished version for improved clarity and flow:
This is a randomized, non-inferiority study comparing radiochemotherapy to radical cystectomy in patients with muscle-invasive bladder cancer. The primary outcome is the evaluation of the non-inferiority of metastasis-free survival between the two treatments.
The study population includes individuals of both sexes, aged 18 years and older, diagnosed with pure or predominant urothelial carcinoma. Participants will be randomized in a 1:1 ratio, with Arm 1 receiving maximal TURBT followed by neoadjuvant chemotherapy and radiotherapy, and Arm 2 receiving TURBT followed by neoadjuvant chemotherapy with cisplatin, followed by radical cystectomy and bilateral pelvic lymphadenectomy.
- Conditions
- Muscle Invasive Bladder Cancer
- Being tested
- Radiochemotherapy, Radical cystectomy
- Keywords
- Bladder cancer, Radiochemotherapy, Radical cystectomy
- 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.
RadiochemotherapyProcedure or surgery
Maximum TURBT will be followed by neoadjuvant chemotherapy with cisplatin at a dose of 35 mg/m². After 2-6 weeks of neoadjuvant chemotherapy, patients will receive radiotherapy for 4 weeks, with concomitant cisplatin at a dose of 40 mg/m² weekly.
Radical cystectomyProcedure or surgery
TURBT will be followed by neoadjuvant chemotherapy with cisplatin at a dose of 35 mg/m², followed by radical cystectomy, bilateral pelvic lymphadenectomy, and reconstruction with either a Bricker procedure or a neobladder.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Maximum TURBT + neoadjuvant chemotherapy with cisplatin + radiotherapy Receives: Procedure: Radiochemotherapy |
| Arm 2 | Other | TURBT + neoadjuvant chemotherapy with cisplatin + radical cystectomy, bilateral pelvic lymphadenectomy + reconstruction Receives: Procedure: Radical cystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metastasis-free survival
The primary outcome is the assessment of the non-inferiority of metastasis-free survival between radiochemotherapy and radical cystectomy.
Measured: The time from the start of treatment until detection of 230 metastases in other organs or tissues outside the bladder (including pelvic lymph nodes).or until death from any cause of the patient, estimated to be up to 8 years
Secondary outcomes (5)
Overall survival
Overall survival of radiochemotherapy versus radical cystectomy.
Measured: The duration from treatment initiation until the study accrues 230 patients with a primary event, or 6 years of follow-up
Muscle-invasive bladder cancer-free survival
Measured: The duration from treatment initiation until the study accrues 230 patients with a primary event, or 6 years of follow-up
Incidence of tumors in the upper tract (in both arms)
The proportion of patients who develop new tumors in the upper urinary tract in 6 years
Measured: The duration from treatment initiation until the study accrues 230 patients with a primary event, or 6 years of follow-up
Adverse Events assessment
All adverse events will be collected and classified according to CTCAE v5.0. The protocol defines the following adverse events of special interest for the Radical Cystectomy group: surgical (infections, bleeding, organ injury, thromboembolism), postoperative (fistula, stricture, hernia, delayed healing), and long-term complications (renal insufficiency, GI disorders, sexual dysfunction, body image issues). And Chemoradiotherapy group: acute effects (cystitis, proctitis, enteritis, nausea, vomiting) and severe toxicities (hematologic toxicity, grade 3-4 diarrhea, skin toxicity).
Measured: The duration from treatment initiation until the study accrues 230 patients with a primary event, or 6 years of follow-up
Quality of Life assessment
Assessment of the perception of patients with bladder cancer about their general well-being, including symptoms of the disease, impact of treatment, psychological and emotional aspects, and the ability to perform physical and social activities, measured through the EORTC QLQ-BLM30 questionnaire.
Measured: The duration from treatment initiation until the study accrues 230 patients with a primary event, or 6 years of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study startDec 2026 (estimated)
- Primary completionDec 2031 (estimated)
- Study completionFeb 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle Invasive Bladder CancerStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 336 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brazilian Clinical Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology, Brazil
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07008833
- Sponsor's protocol ID
- 002/2024
- Other IDs
- 01245.011245/2023-57
- Acronym
- REDEMPTED
- Status last verified
- Oct 2026
- First submitted
- 20 May 2025
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Non-inferiority Study Comparing Radiochemotherapy Versus Radical Cystectomy in Patients With Muscle-invasive Bladder Cancer
- ClinicalTrials.gov ID
- NCT07008833
- Acronym / sponsor ID
- REDEMPTED / 002/2024
- Conditions
- Muscle Invasive Bladder Cancer
- Keywords
- Bladder cancer, Radiochemotherapy, Radical cystectomy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 336 participants (estimated)
- Lead sponsor
- Brazilian Clinical Research InstituteUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology, Brazil
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2031 (estimated)
- Study completion
- Feb 2032 (estimated)
- First posted
- 6 Jun 2025 (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.
Your text is mostly clear and well-structured. Here's a slightly polished version for improved clarity and flow:
This is a randomized, non-inferiority study comparing radiochemotherapy to radical cystectomy in patients with muscle-invasive bladder cancer. The primary outcome is the evaluation of the non-inferiority of metastasis-free survival between the two treatments.
The study population includes individuals of both sexes, aged 18 years and older, diagnosed with pure or predominant urothelial carcinoma. Participants will be randomized in a 1:1 ratio, with Arm 1 receiving maximal TURBT followed by neoadjuvant chemotherapy and radiotherapy, and Arm 2 receiving TURBT followed by neoadjuvant chemotherapy with cisplatin, followed by radical cystectomy and bilateral pelvic lymphadenectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Procedure: RadiochemotherapyMaximum TURBT + neoadjuvant chemotherapy with cisplatin + radiotherapy |
| Arm 2 | Other | Procedure: Radical cystectomyTURBT + neoadjuvant chemotherapy with cisplatin + radical cystectomy, bilateral pelvic lymphadenectomy + reconstruction |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Patients ≥ 18 years of age.
- Pure or predominant urothelial carcinoma (including other histologic subtypes, with the exception of small cell carcinoma, as a minority component).
- Performance status of 0 to 1, according to the Eastern Cooperative Oncology Group (ECOG) criteria.
- Life expectancy of ≥ 3 months.
- Histologically confirmed T2, T3, or T4a stage bladder cancer (pure or predominant urothelial carcinoma) cN0 or cN1 or cN2 (if lymph nodes within the surgical and radiation fields and size ≤ 2 cm).
Key exclusion criteria (18 listed)
- Presence of multiple primary tumors or multiple foci of carcinoma in situ (CIS) (including in the upper tract) that are not candidates for bladder preservation with radiochemotherapy (definition at the discretion of the investigator).
- Age > 80 years.
- Pure adenocarcinoma or pure squamous carcinoma or pure small cell or large cell neuroendocrine carcinoma, micropapillary, sarcomatoid or nested.
- Metastatic or unresectable disease.
- Sensory neuropathy Grade ≥ 2.
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 |
|---|---|---|
| RadiochemotherapyMaximum TURBT will be followed by neoadjuvant chemotherapy with cisplatin at a dose of 35 mg/m². After 2-6 weeks of neoadjuvant chemotherapy, patients will receive radiotherapy for 4 weeks, with concomitant cisplatin at a dose of 40 mg/m² weekly. | Procedure or surgery | Arm 1 |
| Radical cystectomyTURBT will be followed by neoadjuvant chemotherapy with cisplatin at a dose of 35 mg/m², followed by radical cystectomy, bilateral pelvic lymphadenectomy, and reconstruction with either a Bricker procedure or a neobladder. | Procedure or surgery | Arm 2 |
Primary outcome
Metastasis-free survival
Time frame: The time from the start of treatment until detection of 230 metastases in other organs or tissues outside the bladder (including pelvic lymph nodes).or until death from any cause of the patient, estimated to be up to 8 years
The primary outcome is the assessment of the non-inferiority of metastasis-free survival between radiochemotherapy and radical cystectomy.
5 secondary outcomes
Overall survival
Time frame: The duration from treatment initiation until the study accrues 230 patients with a primary event, or 6 years of follow-up
Muscle-invasive bladder cancer-free survival
Time frame: The duration from treatment initiation until the study accrues 230 patients with a primary event, or 6 years of follow-up
Incidence of tumors in the upper tract (in both arms)
Time frame: The duration from treatment initiation until the study accrues 230 patients with a primary event, or 6 years of follow-up
Adverse Events assessment
Time frame: The duration from treatment initiation until the study accrues 230 patients with a primary event, or 6 years of follow-up
Quality of Life assessment
Time frame: The duration from treatment initiation until the study accrues 230 patients with a primary event, or 6 years of follow-up
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 29 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiochemotherapy and Radical cystectomy in people with Muscle Invasive Bladder Cancer, run by Brazilian Clinical Research Institute at 1 site in Brazil.
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 18 inclusion and 18 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: opening soon, as of the sponsor's last update on 29 Oct 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 Brazil. 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.
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?
Contact Fernando C Maluf, MD (55 11 59047339, maluffc@uol.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metastasis-free survival (time frame: The time from the start of treatment until detection of 230 metastases in other organs or tissues outside the bladder (including pelvic lymph nodes).or until death from any cause of the patient, estimated to be up to 8 years). 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 29 Oct 2026.