Bladder CancerPhase 3NCT07914101
Sequential Chemotherapy Followed by Ultrahypofractionated Radiotherapy for Muscle-Invasive Bladder Cancer
A Phase 3 study testing Transurethral Resection of Bladder Tumor, Sequential Systemic Chemotherapy and radiotherapy in people with Bladder Cancer and TURBT, run by Assiut University.
Trial summary
Muscle-invasive bladder cancer (MIBC) is a potentially lethal disease for which radical cystectomy with appropriate systemic therapy remains a standard curative approach in medically fit patients. . Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Bladder Cancer, TURBT, Radiotherapy
- What is being tested?
- Transurethral Resection of Bladder Tumor, Sequential Systemic Chemotherapy and radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 1 Dec 2027
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Histologically confirmed urothelial carcinoma of the urinary bladder
- Muscle-invasive disease, preferably clinical stage cT2-T4a, N0, according to TNM staging system.
- No evidence of distant metastatic disease (M) .
- Age ≥65 years including medically unfit patients for radical cystectomy or radical daily radiotherapy for any reason including but not limited to performance status, comorbidity or patient preferance .
- ECOG performance status 0_ 3.
- Patients must have undergone maximal safe TURBT, with documentation of detrusor muscle in the specimen whenever technically feasible.
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- _Creatinine clearance (CrCl) ≥30 mL/min for patients receiving a carboplatin-based regimen.
- CrCl ≥40 mL/min for patients receiving fractionated cisplatin-based chemotherapy.
- 8- Eligible patients would have an expected survival of greater than 6 months, be willing to accept assessment with cystoscopy following radiotherapy completion and be able to attend for follow-up
Who cannot join
- Nodal disease and distant metastatic disease (M1).
- Previous radiotherapy to the pelvis or any contraindication for pelvic RT including IBD.
- Previous systemic chemotherapy for the current MIBC.
- Uncontrolled active infection, moderate to severe hydronephrosis, invasion of prostatic urethra, diffuse TIS throughout the bladder, tumor size >6 cm.
- Active or history of other malignancy within 2 years of recruitment except for non-melanomatous skin carcinoma, previous non-muscle invasive bladder tumors and low-risk prostate cancer (as defined by NCCN risk stratification as T1/T2a, Gleason 6, PSA <10) will be excluded.
- _ Active Hepatitis B and Hepatitis C.
About this study
Official title: Sequential Chemotherapy Followed by Ultrahypofractionated Radiotherapy for Muscle-Invasive Bladder Cancer in Older Adults: Clinical Outcomes and Treatment-Related Toxicity
Muscle-invasive bladder cancer (MIBC) is a potentially lethal disease for which radical cystectomy with appropriate systemic therapy remains a standard curative approach in medically fit patients. . However, Half of bladder cancer cases are diagnosed in patients aged over 75 years, many of whom are not fit for major surgery owing to their performance status and comorbidities .
A substantial proportion of bladder cancer cases occur in older adults (there is no single universal age cutoff for the term older adults, but several commonly used definitions exist: WHO: generally refers to people aged 60 years or older, particularly in low- and middle-income countries, while in clinical and research settings: ≥65 years is frequently used as the operational definition of older adults, especially in oncology and geriatric medicine), and advanced age is frequently accompanied by comorbidities and frailty that may limit eligibility for radical surgery or multimodality treatment . Bladder-preserving treatment incorporating maximal transurethral resection of bladder tumor (TURBT) and definitive radiotherapy is therefore an important treatment option in selected patients.
Read the detailed description
Muscle-invasive bladder cancer (MIBC) is a potentially lethal disease for which radical cystectomy with appropriate systemic therapy remains a standard curative approach in medically fit patients. However, Half of bladder cancer cases are diagnosed in patients aged over 75 years, many of whom are not fit for major surgery owing to their performance status and comorbidities .
A substantial proportion of bladder cancer cases occur in older adults (there is no single universal age cutoff for the term older adults, but several commonly used definitions exist: WHO: generally refers to people aged 60 years or older, particularly in low- and middle-income countries, while in clinical and research settings: ≥65 years is frequently used as the operational definition of older adults, especially in oncology and geriatric medicine), and advanced age is frequently accompanied by comorbidities and frailty that may limit eligibility for radical surgery or multimodality treatment. Bladder-preserving treatment incorporating maximal transurethral resection of bladder tumor (TURBT) and definitive radiotherapy is therefore an important treatment option in selected patients.
Most established bladder-preservation protocols use concurrent chemoradiotherapy. Nevertheless, sequential treatment-systemic chemotherapy followed by definitive radiotherapy-may be attractive in selected patients . Published data support bladder-preserving radiotherapy in older adults, although the literature is heterogeneous and most contemporary series evaluate concurrent rather than purely sequential treatment . In Older adults, concurrent chemoradiotherapy has been associated with improved survival, while hypofractionated bladder radiotherapy schedules have demonstrated acceptable tolerability in selected older populations .
These observations provide the rationale for prospectively evaluating a sequential approach in patients who are not ideal candidates for concurrent chemoradiotherapy. A number of small single-centre studies using the higher biological dose of 30-36 Gy in 6 Gy per fraction suggest acceptable acute and late toxicity with local control achieved in over of 60% patients at 3 months . Prospective multicentre assessment of this radiotherapy schedule has not yet been performed. The proposed study will evaluate the feasibility, efficacy, treatment completion, and toxicity of a sequential strategy in older adults with non-metastatic MIBC.
- Conditions
- Bladder Cancer, TURBT, Radiotherapy
- Being tested
- Transurethral Resection of Bladder Tumor, Sequential Systemic Chemotherapy, radiotherapy
- 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.
Transurethral Resection of Bladder TumorProcedure or surgery
All patients should undergo maximal safe TURBT before systemic treatment. The objective is maximal tumor debulking while preserving bladder function and obtaining adequate tissue for pathological diagnosis and staging. A second-look TURBT may be considered, especially when the initial resection was incomplete (tumors ≥3 cm, no evaluation of muscle involvement in spite of radiological evidence).
Sequential Systemic ChemotherapyDrug
Systemic chemotherapy will be administered before radiotherapy. The preferred regimen should be selected according to renal function, performance status, comorbidities, and multidisciplinary assessment.
Suggested protocol options:
- Cisplatin-eligible patients: Gemcitabine + cisplatin may be used commonly for 3-4 cycles.
- Cisplatin-ineligible patients: Gemcitabine + carboplatin may be considered where appropriate .
Radiotherapy should commence after adequate recovery from chemotherapy, provided there is no evidence of progression and the patient remains suitable for local treatment. A practical interval is approximately 3-6 weeks after the final chemotherapy cycle.
radiotherapyRadiation
Three-dimensional conformal radiotherapy planning is recommended using three or four fields; however, use of static 5-7-field IMRT or volumetric modulated arc radiotherapy treatment is permitted.
Three-dimensional dose distributions will be produced for the overall prescribed dose of 36 Gy in six fractions. The dose distribution will be assessed for coverage of the PTV and normal tissues sparing using appropriate transverse sagittal and coronal views.
All plans will be created to ensure that at least 98% of the PTV (PTV D98%) receives >90% (ideally >95%) of the prescribed dose, the median PTV dose (PTV D50%) is within 1% of the prescription dose and the near maximum (PTV D2%) is <107% (ideally <105%) of the prescribed dose. To minimize unexpected high dose outside the PTV, it is required that 1 cm3 of normal tissue outside the PTV should be <110% of the prescribed dose.
| Study group | Role | What they receive |
|---|---|---|
| Older adults with muscle invasive bladder cancer | Experimental | Patients aged ≥65 years with histologically confirmed muscle-invasive urothelial carcinoma of the urinary bladder with non-metastatic disease and with PS 0-3, who are medically unfit or unsuitable for radical cystectomy or radical conventional RT, will be treated with sequential chemotherapy followed by ultrahypofractionated radiotherapy will be considered for enrollment. Receives: Procedure: Transurethral Resection of Bladder Tumor; Drug: Sequential Systemic Chemotherapy; Radiation: radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of objective Response rate (ORR) and Disease control rate (DCR)
Evaluate the Clinical efficacy including Objective Response rate (ORR) and Disease control rate (DCR) at 4-6 weeks after finishing RT.
Measured: 4-6 weeks after completion of RT
Assessment of Toxicity of Treatment
Evaluate Toxicity of Treatment using Common Terminology Criteria for Adverse Events (CTCAE V.5)
Measured: Baseline
Assessment of Toxicity of Treatment
Assessment of treatment-related toxicity according to health-related quality of life using the EQ-5D questionnaire
Measured: Baseline
Secondary outcomes (2)
Assess the Time to local disease progression
Time from the date of treatment initiation to the date of documented local disease progression
Measured: From treatment initiation until the end of the follow up ( 12 months follow up )
Assess the Time to EFS
Time from the date of treatment initiation to Event free survival
Measured: From treatment initiation until progression or death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- A prospective, single-arm, interventional , clinical study.
- Masking
- None (open label)
- Enrolment
- 71 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walaa Khalifa Fathy Mohammed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07914101
- Sponsor's protocol ID
- Ultrafractionated Radiotherapy
- Status last verified
- Oct 2026
- First submitted
- 26 Sep 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sequential Chemotherapy Followed by Ultrahypofractionated Radiotherapy for Muscle-Invasive Bladder Cancer in Older Adults: Clinical Outcomes and Treatment-Related Toxicity
- ClinicalTrials.gov ID
- NCT07914101
- Acronym / sponsor ID
- Ultrafractionated Radiotherapy
- Conditions
- Bladder Cancer, TURBT, Radiotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 71 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 3 Nov 2026 (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.
Muscle-invasive bladder cancer (MIBC) is a potentially lethal disease for which radical cystectomy with appropriate systemic therapy remains a standard curative approach in medically fit patients. . However, Half of bladder cancer cases are diagnosed in patients aged over 75 years, many of whom are not fit for major surgery owing to their performance status and comorbidities .
A substantial proportion of bladder cancer cases occur in older adults (there is no single universal age cutoff for the term older adults, but several commonly used definitions exist: WHO: generally refers to people aged 60 years or older, particularly in low- and middle-income countries, while in clinical and research settings: ≥65 years is frequently used as the operational definition of older adults, especially in oncology and geriatric medicine), and advanced age is frequently accompanied by comorbidities and frailty that may limit eligibility for radical surgery or multimodality treatment . Bladder-preserving treatment incorporating maximal transurethral resection of bladder tumor (TURBT) and definitive radiotherapy is therefore an important treatment option in selected patients.
Detailed description
Muscle-invasive bladder cancer (MIBC) is a potentially lethal disease for which radical cystectomy with appropriate systemic therapy remains a standard curative approach in medically fit patients. However, Half of bladder cancer cases are diagnosed in patients aged over 75 years, many of whom are not fit for major surgery owing to their performance status and comorbidities .
A substantial proportion of bladder cancer cases occur in older adults (there is no single universal age cutoff for the term older adults, but several commonly used definitions exist: WHO: generally refers to people aged 60 years or older, particularly in low- and middle-income countries, while in clinical and research settings: ≥65 years is frequently used as the operational definition of older adults, especially in oncology and geriatric medicine), and advanced age is frequently accompanied by comorbidities and frailty that may limit eligibility for radical surgery or multimodality treatment. Bladder-preserving treatment incorporating maximal transurethral resection of bladder tumor (TURBT) and definitive radiotherapy is therefore an important treatment option in selected patients.
Most established bladder-preservation protocols use concurrent chemoradiotherapy. Nevertheless, sequential treatment-systemic chemotherapy followed by definitive radiotherapy-may be attractive in selected patients . Published data support bladder-preserving radiotherapy in older adults, although the literature is heterogeneous and most contemporary series evaluate concurrent rather than purely sequential treatment . In Older adults, concurrent chemoradiotherapy has been associated with improved survival, while hypofractionated bladder radiotherapy schedules have demonstrated acceptable tolerability in selected older populations .
These observations provide the rationale for prospectively evaluating a sequential approach in patients who are not ideal candidates for concurrent chemoradiotherapy. A number of small single-centre studies using the higher biological dose of 30-36 Gy in 6 Gy per fraction suggest acceptable acute and late toxicity with local control achieved in over of 60% patients at 3 months . Prospective multicentre assessment of this radiotherapy schedule has not yet been performed. The proposed study will evaluate the feasibility, efficacy, treatment completion, and toxicity of a sequential strategy in older adults with non-metastatic MIBC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A prospective, single-arm, interventional , clinical study.
| Arm | Type | Receives |
|---|---|---|
| Older adults with muscle invasive bladder cancer | Experimental | Procedure: Transurethral Resection of Bladder Tumor, Drug: Sequential Systemic Chemotherapy, Radiation: radiotherapyPatients aged ≥65 years with histologically confirmed muscle-invasive urothelial carcinoma of the urinary bladder with non-metastatic disease and with PS 0-3, who are medically unfit or unsuitable for radical cystectomy or radical conventional RT, will be treated with sequential chemotherapy followed by ultrahypofractionated radiotherapy will be considered for enrollment. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- Histologically confirmed urothelial carcinoma of the urinary bladder
- Muscle-invasive disease, preferably clinical stage cT2-T4a, N0, according to TNM staging system.
- No evidence of distant metastatic disease (M) .
- Age ≥65 years including medically unfit patients for radical cystectomy or radical daily radiotherapy for any reason including but not limited to performance status, comorbidity or patient preferance .
- ECOG performance status 0_ 3.
Key exclusion criteria (6 listed)
- Nodal disease and distant metastatic disease (M1).
- Previous radiotherapy to the pelvis or any contraindication for pelvic RT including IBD.
- Previous systemic chemotherapy for the current MIBC.
- Uncontrolled active infection, moderate to severe hydronephrosis, invasion of prostatic urethra, diffuse TIS throughout the bladder, tumor size >6 cm.
- Active or history of other malignancy within 2 years of recruitment except for non-melanomatous skin carcinoma, previous non-muscle invasive bladder tumors and low-risk prostate cancer (as defined by NCCN risk stratification as T1/T2a, Gleason 6, PSA <10) will be excluded.
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 |
|---|---|---|
| Transurethral Resection of Bladder TumorAll patients should undergo maximal safe TURBT before systemic treatment. The objective is maximal tumor debulking while preserving bladder function and obtaining adequate tissue for pathological diagnosis and staging. A second-look TURBT may be considered, especially when the initial resection was incomplete (tumors ≥3 cm, no evaluation of muscle involvement in spite of radiological evidence). | Procedure or surgery | Older adults with muscle invasive bladder cancer |
| Sequential Systemic ChemotherapySystemic chemotherapy will be administered before radiotherapy. The preferred regimen should be selected according to renal function, performance status, comorbidities, and multidisciplinary assessment. Suggested protocol options: * Cisplatin-eligible patients: Gemcitabine + cisplatin may be used commonly for 3-4 cycles. * Cisplatin-ineligible patients: Gemcitabine + carboplatin may be considered where appropriate . Radiotherapy should commence after adequate recovery from chemotherapy, provided there is no evidence of progression and the patient remains suitable for local treatment. A practical interval is approximately 3-6 weeks after the final chemotherapy cycle. | Drug | Older adults with muscle invasive bladder cancer |
| radiotherapyThree-dimensional conformal radiotherapy planning is recommended using three or four fields; however, use of static 5-7-field IMRT or volumetric modulated arc radiotherapy treatment is permitted. Three-dimensional dose distributions will be produced for the overall prescribed dose of 36 Gy in six fractions. The dose distribution will be assessed for coverage of the PTV and normal tissues sparing using appropriate transverse sagittal and coronal views. All plans will be created to ensure that at least 98% of the PTV (PTV D98%) receives >90% (ideally >95%) of the prescribed dose, the median PTV dose (PTV D50%) is within 1% of the prescription dose and the near maximum (PTV D2%) is <107% (ideally <105%) of the prescribed dose. To minimize unexpected high dose outside the PTV, it is required that 1 cm3 of normal tissue outside the PTV should be <110% of the prescribed dose. | Radiation | Older adults with muscle invasive bladder cancer |
Primary outcome
Assessment of objective Response rate (ORR) and Disease control rate (DCR)
Time frame: 4-6 weeks after completion of RT
Evaluate the Clinical efficacy including Objective Response rate (ORR) and Disease control rate (DCR) at 4-6 weeks after finishing RT.
Assessment of Toxicity of Treatment
Time frame: Baseline
Evaluate Toxicity of Treatment using Common Terminology Criteria for Adverse Events (CTCAE V.5)
Assessment of Toxicity of Treatment
Time frame: Baseline
Assessment of treatment-related toxicity according to health-related quality of life using the EQ-5D questionnaire
2 secondary outcomes
Assess the Time to local disease progression
Time frame: From treatment initiation until the end of the follow up ( 12 months follow up )
Assess the Time to EFS
Time frame: From treatment initiation until progression or death
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 3 Nov 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Transurethral Resection of Bladder Tumor, Sequential Systemic Chemotherapy and radiotherapy in people with Bladder Cancer and TURBT, run by Assiut University.
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 9 inclusion and 6 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 3 Nov 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 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?
Assessment of objective Response rate (ORR) and Disease control rate (DCR) (time frame: 4-6 weeks after completion of RT). The study lists 3 primary outcomes in all. 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 3 Nov 2026.