Non Muscle Invasive Bladder CancerNCT07873333
The Role of Definitive Radiotherapy in Non Muscle Invasive Bladder Cancer
A study testing Definitive radiotherapy, BCG and Concurrent chemotherapy in people with Non Muscle Invasive Bladder Cancer, run by Assiut University.
Trial summary
Bladder cancer is one of the most common malignancies worldwide and represents a major global health burden. According to the GLOBOCAN 2022 estimates, approximately 614,298 new cases and 220,596 deaths from bladder cancer were reported worldwide, making it the ninth most commonly diagnosed malignancy globally. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Muscle Invasive Bladder Cancer
- What is being tested?
- Definitive radiotherapy, BCG and Concurrent chemotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 2 Oct 2026to Dec 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1-Adults aged ≥18 years at the time of enrollment. 2-Histologically confirmed high-risk NMIBC 3-BCG-naïve patients . 4-(ECOG) performance status of 0-2. 5-Informed Consent
Who cannot join
- 1-Previous pelvic radiotherapy . 2-Inadequate pathological assessment 3-Another active malignancy . 4-Patient non complaint to follow up. 5-BCG toxicity occurence.
About this study
Official title: Evaluating the Role of Definitive Radiotherapy in High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC): A Randamized Controlled Trial (RCT)
Bladder cancer is one of the most common malignancies worldwide and represents a major global health burden. According to the GLOBOCAN 2022 estimates, approximately 614,298 new cases and 220,596 deaths from bladder cancer were reported worldwide, making it the ninth most commonly diagnosed malignancy globally.
Non-muscle-invasive bladder cancer (NMIBC), comprising Ta, T1, and carcinoma in situ (CIS), accounts for approximately three-quarters of newly diagnosed bladder cancers. Although NMIBC is confined to the mucosa or submucosa, it represents a heterogeneous group of tumors with markedly different risks of recurrence and progression, with the highest risk observed in high-grade and high-risk disease.
Read more
NMIBC is classified according to the risk of recurrence and progression into low-, intermediate-, high-, and very-high-risk groups. Risk stratification incorporates tumor stage, histological grade, tumor size, number of tumors, recurrence pattern, presence of CIS, age, and other adverse pathological and clinical features. High-grade histology, particularly T1 high-grade disease, is associated with a substantially increased risk of progression to muscle-invasive bladder cancer.
Risk Stratification of Non-Muscle-Invasive Bladder Cancer Risk group Main clinical and pathological characteristics Low-risk Primary, solitary, small low-grade Ta tumor without CIS and without significant adverse risk factors Intermediate-risk Tumors that do not fulfill the criteria for low-, high-, or very-high-risk disease High-risk Includes high-grade T1 tumors and CIS, as well as selected high-grade Ta/T1 tumors with additional adverse risk factors Very-high-risk High-grade tumors with multiple adverse features, including selected T1 high-grade tumors associated with CIS and/or multiple additional risk factors Risk classification should follow current guideline-defined criteria and should not be based on histological grade alone.
The management of high-risk NMIBC is based on complete transurethral resection of the bladder tumor (TURBT), followed by risk-adapted intravesical therapy. Full-dose intravesical Bacillus Calmette-Guérin (BCG) with maintenance therapy for one to three years remains an established standard treatment for high-risk disease, while radical cystectomy should be discussed in selected patients, particularly those with very-high-risk features.
T1 high-grade disease represents a particularly challenging subgroup because of its substantial potential for recurrence and progression despite bladder-preserving treatment. Clinical series of patients treated with TURBT followed by BCG have demonstrated considerable rates of both recurrent and progressive disease, emphasizing the need for effective treatment strategies in patients at high risk of treatment failure.
Radiotherapy has historically had a limited role in NMIBC. Nevertheless, its biological activity against urothelial carcinoma and its established role in bladder-preserving treatment of selected muscle-invasive bladder cancer have provided a rationale for investigating radiotherapy at earlier stages of bladder cancer. Modern radiotherapy techniques may allow treatment of the bladder while limiting radiation exposure to surrounding normal tissues.
Clinical evidence for radiotherapy in high-risk NMIBC has been reported since the early 1980s. Retrospective series evaluating radiotherapy in high-risk T1 bladder cancer demonstrated clinically meaningful complete response rates, local control, long-term survival, and bladder preservation. These findings suggest that radiotherapy may represent a potential bladder-preserving treatment option in carefully selected patients.
A systematic review and meta-analysis evaluating radiotherapy for high-risk NMIBC identified 13 studies involving 746 patients. The reported five-year recurrence-free survival, cancer-specific survival, and overall survival were 54%, 86%, and 72%, respectively. Approximately 13% of patients subsequently underwent salvage radical cystectomy and 9% developed metastatic disease. However, the available evidence was considered low quality because most studies were retrospective and heterogeneous, emphasizing the need for prospective clinical evaluation.
The potential role of radiotherapy in BCG-naïve high-risk NMIBC is of clinical interest because it could provide a bladder-preserving local treatment approach without prolonged intravesical therapy in selected patients. However, current guidelines do not consider radiotherapy a standard replacement for BCG-naïve high-risk NMIBC, and prospective evidence remains limited.
Therefore, there is a need for prospective evaluation of radiotherapy as a bladder-preserving treatment strategy in selected patients with high-risk NMIBC, who present without previous BCG exposure, and Evaluation of local disease control, bladder preservation, progression, survival, and treatment-related toxicity may help clarify the potential role of RTH
Read the detailed description
Pre-treatment Assessment All patients will undergo complete clinical and pathological assessment before treatment.
Evaluation will include:
- Complete history and physical examination.
- Histopathological confirmation following TURBT.
- Assessment of tumor stage and grade with contrast enhanced MsCT Chest, pelviabdomen or contrast enhanced MRI .
- Assessment of CIS and other adverse pathological features.
- Confirmation of BCG-naïve status.
Treatment Strategy All patients with suspected non-muscle-invasive bladder cancer (NMIBC) will undergo an initial transurethral resection of bladder tumour (TURBT) for complete removal of all visible tumour and accurate histopathological diagnosis and staging. a second look TURBT will be performed when the initial resection is incomplete or there is doubt regarding its completeness, when detrusor muscle is absent from the initial specimen except in Ta low-grade/G1 tumours and primary carcinoma in situ (CIS), and in all patients with T1 disease. The second TURBT will be performed within 2-6 weeks after the initial TURBT and will include re-resection of the previous tumour site to detect and remove residual disease and to ensure accurate pathological staging.(2)
ARM1(patient allocated to concurrent chemoradiotherapy) After complete TURBT, patient will start definitive concurrent chemoradiotherapy.
Radiotherapy will be delivered as definitive external beam radiotherapy with concurrent chemotherapy as a radiosensitizer.
Radiotherapy will be delivered using a modern conformal technique with appropriate bladder and pelvic organ-at-risk delineation.
RT will be initiated 4 to 6 weeks after initial TURBT using 3D-conformal external beam radiotherapy (3D-CRT) to the bladder, with a total dose of 55 Gy in 20 fractions over 4 weeks , with weekly concurrent radiosensitizing chemotherapy selected by treating physicion according to institutional practice.
ARM2(patient allocated to intravesical BCG therapy) After complete TURBT, patient will start intravesical BCG therapy after a recovery period of at least two weeks before initiation.
then patient will receive standard full-dose intravesical Bacillus Calmette-Guérin (BCG) therapy, BCG induction therapy will consist of one intravesical instillation administered once weekly for six consecutive weeks, Maintenance BCG will subsequently be administered as three consecutive weekly intravesical instillations at 3, 6, 12, 18, and 24 months from the initiation of BCG therapy. Thus, during the two-year follow-up period.
Assesment of treatment response
Patients will undergo regular clinical follow-up every 3 months for a minimum 2 years with :
- Contrast enhanced MsCT Chest, pelviabdomen or contrast enhanced MRI .
- Cystoscopic evaluation: The gold standard for examining the mucosal lining of the bladder.
- Urinary cytology:Used alongside cystoscopy in high-risk patients to detect high-grade microscopic tumor cells.
- TURBT will be performed when clinically indicated, upon detection of visual recurrence or positive cytology.
- Conditions
- Non Muscle Invasive Bladder Cancer
- Being tested
- Definitive radiotherapy, BCG, Concurrent chemotherapy
- Keywords
- Radiotherapy, Bladder cancer, NMIBC
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms, Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Definitive radiotherapyRadiation
3D-conformal external beam radiotherapy (3D-CRT) to the bladder, with a total dose of 55 Gy in 20 fractions over 4 weeks
BCGBiological
intravesical instillation administered once weekly for six consecutive weeks, Maintenance BCG will subsequently be administered as three consecutive weekly intravesical instillations at 3, 6, 12, 18, and 24 months from the initiation of BCG therapy. Thus, during the two-year follow-up period.
Concurrent chemotherapyDrug
weekly concurrent radiosensitizing chemotherapy will be used along with radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| patients will receive conventional 3D radiotherapy with concurrent chemotherapy. | Experimental | Not described Receives: Radiation: Definitive radiotherapy; Drug: Concurrent chemotherapy |
| patients will receive intravesical BCG therapy. | Active comparator | Not described Receives: Biological: BCG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response (CR) Rate
Complete response is defined as negative cystoscopy and negative urinary cytology.
Measured: 6 months after completion of treatment
Secondary outcomes (1)
Treatment-Related Toxicity
Incidence, severity, and type of treatment-related adverse events, graded according to CTCAE version 5.0.
Measured: From initiation of treatment through 2 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 posted14 Oct 2026
- Study start2 Oct 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Muscle Invasive 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Youanna Talaat Fahem, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07873333
- Sponsor's protocol ID
- Radiotherapy in NMIBC
- Status last verified
- Oct 2026
- First submitted
- 2 Oct 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Role of Definitive Radiotherapy in High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC): A Randamized Controlled Trial (RCT)
- ClinicalTrials.gov ID
- NCT07873333
- Acronym / sponsor ID
- Radiotherapy in NMIBC
- Conditions
- Non Muscle Invasive Bladder Cancer
- Keywords
- Radiotherapy, Bladder cancer, NMIBC
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 2 Oct 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 14 Oct 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.
Bladder cancer is one of the most common malignancies worldwide and represents a major global health burden. According to the GLOBOCAN 2022 estimates, approximately 614,298 new cases and 220,596 deaths from bladder cancer were reported worldwide, making it the ninth most commonly diagnosed malignancy globally.
Non-muscle-invasive bladder cancer (NMIBC), comprising Ta, T1, and carcinoma in situ (CIS), accounts for approximately three-quarters of newly diagnosed bladder cancers. Although NMIBC is confined to the mucosa or submucosa, it represents a heterogeneous group of tumors with markedly different risks of recurrence and progression, with the highest risk observed in high-grade and high-risk disease.
NMIBC is classified according to the risk of recurrence and progression into low-, intermediate-, high-, and very-high-risk groups. Risk stratification incorporates tumor stage, histological grade, tumor size, number of tumors, recurrence pattern, presence of CIS, age, and other adverse pathological and clinical features. High-grade histology, particularly T1 high-grade disease, is associated with a substantially increased risk of progression to muscle-invasive bladder cancer.
Risk Stratification of Non-Muscle-Invasive Bladder Cancer Risk group Main clinical and pathological characteristics Low-risk Primary, solitary, small low-grade Ta tumor without CIS and without significant adverse risk factors Intermediate-risk Tumors that do not fulfill the criteria for low-, high-, or very-high-risk disease High-risk Includes high-grade T1 tumors and CIS, as well as selected high-grade Ta/T1 tumors with additional adverse risk factors Very-high-risk High-grade tumors with multiple adverse features, including selected T1 high-grade tumors associated with CIS and/or multiple additional risk factors Risk classification should follow current guideline-defined criteria and should not be based on histological grade alone.
The management of high-risk NMIBC is based on complete transurethral resection of the bladder tumor (TURBT), followed by risk-adapted intravesical therapy. Full-dose intravesical Bacillus Calmette-Guérin (BCG) with maintenance therapy for one to three years remains an established standard treatment for high-risk disease, while radical cystectomy should be discussed in selected patients, particularly those with very-high-risk features.
T1 high-grade disease represents a particularly challenging subgroup because of its substantial potential for recurrence and progression despite bladder-preserving treatment. Clinical series of patients treated with TURBT followed by BCG have demonstrated considerable rates of both recurrent and progressive disease, emphasizing the need for effective treatment strategies in patients at high risk of treatment failure.
Radiotherapy has historically had a limited role in NMIBC. Nevertheless, its biological activity against urothelial carcinoma and its established role in bladder-preserving treatment of selected muscle-invasive bladder cancer have provided a rationale for investigating radiotherapy at earlier stages of bladder cancer. Modern radiotherapy techniques may allow treatment of the bladder while limiting radiation exposure to surrounding normal tissues.
Clinical evidence for radiotherapy in high-risk NMIBC has been reported since the early 1980s. Retrospective series evaluating radiotherapy in high-risk T1 bladder cancer demonstrated clinically meaningful complete response rates, local control, long-term survival, and bladder preservation. These findings suggest that radiotherapy may represent a potential bladder-preserving treatment option in carefully selected patients.
A systematic review and meta-analysis evaluating radiotherapy for high-risk NMIBC identified 13 studies involving 746 patients. The reported five-year recurrence-free survival, cancer-specific survival, and overall survival were 54%, 86%, and 72%, respectively. Approximately 13% of patients subsequently underwent salvage radical cystectomy and 9% developed metastatic disease. However, the available evidence was considered low quality because most studies were retrospective and heterogeneous, emphasizing the need for prospective clinical evaluation.
The potential role of radiotherapy in BCG-naïve high-risk NMIBC is of clinical interest because it could provide a bladder-preserving local treatment approach without prolonged intravesical therapy in selected patients. However, current guidelines do not consider radiotherapy a standard replacement for BCG-naïve high-risk NMIBC, and prospective evidence remains limited.
Therefore, there is a need for prospective evaluation of radiotherapy as a bladder-preserving treatment strategy in selected patients with high-risk NMIBC, who present without previous BCG exposure, and Evaluation of local disease control, bladder preservation, progression, survival, and treatment-related toxicity may help clarify the potential role of RTH
Detailed description
Pre-treatment Assessment All patients will undergo complete clinical and pathological assessment before treatment.
Evaluation will include:
- Complete history and physical examination.
- Histopathological confirmation following TURBT.
- Assessment of tumor stage and grade with contrast enhanced MsCT Chest, pelviabdomen or contrast enhanced MRI .
- Assessment of CIS and other adverse pathological features.
- Confirmation of BCG-naïve status.
Treatment Strategy All patients with suspected non-muscle-invasive bladder cancer (NMIBC) will undergo an initial transurethral resection of bladder tumour (TURBT) for complete removal of all visible tumour and accurate histopathological diagnosis and staging. a second look TURBT will be performed when the initial resection is incomplete or there is doubt regarding its completeness, when detrusor muscle is absent from the initial specimen except in Ta low-grade/G1 tumours and primary carcinoma in situ (CIS), and in all patients with T1 disease. The second TURBT will be performed within 2-6 weeks after the initial TURBT and will include re-resection of the previous tumour site to detect and remove residual disease and to ensure accurate pathological staging.(2)
ARM1(patient allocated to concurrent chemoradiotherapy) After complete TURBT, patient will start definitive concurrent chemoradiotherapy.
Radiotherapy will be delivered as definitive external beam radiotherapy with concurrent chemotherapy as a radiosensitizer.
Radiotherapy will be delivered using a modern conformal technique with appropriate bladder and pelvic organ-at-risk delineation.
RT will be initiated 4 to 6 weeks after initial TURBT using 3D-conformal external beam radiotherapy (3D-CRT) to the bladder, with a total dose of 55 Gy in 20 fractions over 4 weeks , with weekly concurrent radiosensitizing chemotherapy selected by treating physicion according to institutional practice.
ARM2(patient allocated to intravesical BCG therapy) After complete TURBT, patient will start intravesical BCG therapy after a recovery period of at least two weeks before initiation.
then patient will receive standard full-dose intravesical Bacillus Calmette-Guérin (BCG) therapy, BCG induction therapy will consist of one intravesical instillation administered once weekly for six consecutive weeks, Maintenance BCG will subsequently be administered as three consecutive weekly intravesical instillations at 3, 6, 12, 18, and 24 months from the initiation of BCG therapy. Thus, during the two-year follow-up period.
Assesment of treatment response
Patients will undergo regular clinical follow-up every 3 months for a minimum 2 years with :
- Contrast enhanced MsCT Chest, pelviabdomen or contrast enhanced MRI .
- Cystoscopic evaluation: The gold standard for examining the mucosal lining of the bladder.
- Urinary cytology:Used alongside cystoscopy in high-risk patients to detect high-grade microscopic tumor cells.
- TURBT will be performed when clinically indicated, upon detection of visual recurrence or positive cytology.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients will receive conventional 3D radiotherapy with concurrent chemotherapy. | Experimental | Radiation: Definitive radiotherapy, Drug: Concurrent chemotherapy |
| patients will receive intravesical BCG therapy. | Active comparator | Biological: BCG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1-Adults aged ≥18 years at the time of enrollment. 2-Histologically confirmed high-risk NMIBC 3-BCG-naïve patients . 4-(ECOG) performance status of 0-2. 5-Informed Consent
Key exclusion criteria (1 listed)
- 1-Previous pelvic radiotherapy . 2-Inadequate pathological assessment 3-Another active malignancy . 4-Patient non complaint to follow up. 5-BCG toxicity occurence.
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 |
|---|---|---|
| Definitive radiotherapy3D-conformal external beam radiotherapy (3D-CRT) to the bladder, with a total dose of 55 Gy in 20 fractions over 4 weeks | Radiation | patients will receive conventional 3D radiotherapy with concurrent chemotherapy. |
| BCGintravesical instillation administered once weekly for six consecutive weeks, Maintenance BCG will subsequently be administered as three consecutive weekly intravesical instillations at 3, 6, 12, 18, and 24 months from the initiation of BCG therapy. Thus, during the two-year follow-up period. | Biological | patients will receive intravesical BCG therapy. |
| Concurrent chemotherapyweekly concurrent radiosensitizing chemotherapy will be used along with radiotherapy | Drug | patients will receive conventional 3D radiotherapy with concurrent chemotherapy. |
Primary outcome
Complete Response (CR) Rate
Time frame: 6 months after completion of treatment
Complete response is defined as negative cystoscopy and negative urinary cytology.
1 secondary outcome
Treatment-Related Toxicity
Time frame: From initiation of treatment through 2 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 14 Oct 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 study testing Definitive radiotherapy, BCG and Concurrent chemotherapy in people with Non Muscle Invasive Bladder Cancer, 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 1 inclusion and 1 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 14 Oct 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.
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?
Complete Response (CR) Rate (time frame: 6 months after completion of treatment). 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 14 Oct 2026.