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Sequential Chemotherapy Followed by Ultrahypofractionated Radiotherapy for Muscle-Invasive Bladder Cancer
Sponsor: Assiut University
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. . 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.
Official title: Sequential Chemotherapy Followed by Ultrahypofractionated Radiotherapy for Muscle-Invasive Bladder Cancer in Older Adults: Clinical Outcomes and Treatment-Related Toxicity
Key Details
Gender
All
Age Range
65 Years - Any
Study Type
INTERVENTIONAL
Enrollment
71
Start Date
2026-12-01
Completion Date
2027-12-01
Last Updated
2026-11-03
Healthy Volunteers
No
Conditions
Interventions
Transurethral Resection of Bladder Tumor
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 Chemotherapy
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.
radiotherapy
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.