NCT07914101Not yet recruitingPhase 3
Sequential Chemotherapy Followed by Ultrahypofractionated Radiotherapy for Muscle-Invasive Bladder Cancer
Sequential Chemotherapy Followed by Ultrahypofractionated Radiotherapy for Muscle-Invasive Bladder Cancer in Older Adults: Clinical Outcomes and Treatment-Related Toxicity
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 71 (estimated)
- First submitted
- 26 Sept 2026
- Start date
- 1 Dec 2026
- Primary completion date
- 1 Aug 2027
- Lead sponsor
- Assiut University
- Diseases
- Bladder cancer
- NCT number
- NCT07914101
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 71
- From 1 Dec 2026 to the primary completion date, 1 Aug 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous radiotherapy to the pelvis or any contraindication for pelvic RT including IBD.
- Previous systemic chemotherapy for the current MIBC.
Other illness
- Nodal disease and distant metastatic disease (M1).
- 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.
Who the study is looking for
- 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.
- \_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
Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.