Clinical trial · Interventional
3-Dimensional Conformal Radiation Therapy in Treating Patients With Bladder Cancer Who Have Undergone Transurethral Resection of the Bladder
Image Guided Dose Escalated Adaptive Bladder Radiotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. PURPOSE: This phase I trial is studying the side effects and best dose of 3-dimensional conformal radiation therapy in treating patients with bladder cancer who have undergone transurethral resection of the bladder.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3-dimensional conformal radiation therapy | Radiation | — | UNRESOLVED |
| diagnostic cystoscopy | Procedure | — | UNRESOLVED |
| diffusion-weighted magnetic resonance imaging | Procedure | — | UNRESOLVED |
| image-guided radiation therapy | Radiation | — | UNRESOLVED |
| implanted fiducial-based imaging | Procedure | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
| selective external radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Maximum-tolerated dose
Secondary outcomes (8)
- measure
- Progression-free survival
- measure
- Overall survival
- measure
- Bladder preservation rates
- measure
- Acute and late toxicity and safety profile
- measure
- Quality of life
- measure
- Tumor boost volumes delineated with and without gold seeds
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed invasive bladder carcinoma, including the following cellular types: * Adenocarcinoma * Transitional cell carcinoma * Squamous cell carcinoma * Clinical stage G1-3, pT2a-4 disease * Localized disease * No bone or visceral metastases * No lymph node metastases * Has undergone maximal transurethral resection of the bladder tumor and planning to receive radical radiotherapy PATIENT CHARACTERISTICS: * WHO performance status 0-1 * Hemoglobin \> 10 g/dL * WBC \> 3,000/mm\^3 * Platelet count \> 150,000/mm\^3 * Creatinine \< 120 μmol/L * Bilirubin \< 1.5 times upper limit normal (ULN) * AST \< 1.5 times ULN * Alkaline phosphatase \< 1.5 times ULN * Not pregnant * No inflammatory bowel disease or other significant small bowel disease * Physically fit for radical radiotherapy * No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule * No other malignancy within the past 2 years except adequately treated basal cell carcinoma of the skin or adequately treated carcinoma in situ of the cervix uteri * Prior superficial transitional cell carcinoma of the bladder allowed PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior pelvic surgery * No bilateral hip replacements compromising accurate radiotherapy planning * No prior radiotherapy to the pelvis
References
Publications (1)
- DERIVEDHafeez S, Warren-Oseni K, Jones K, Mohammed K, El-Ghzal A, Dearnaley D, Harris V, Khan A, Kumar P, Lalondrelle S, McDonald F, Tan M, Thomas K, Thompson A, McNair HA, Hansen VN, Huddart RA. Bladder Tumor-Focused Adaptive Radiation Therapy: Clinical Outcomes of a Phase I Dose Escalation Study. Int J Radiat Oncol Biol Phys. 2025 Jan 1;121(1):165-175. doi: 10.1016/j.ijrobp.2024.07.2317. Epub 2024 Jul 26. PMID 39069239