Clinical trial · Interventional
Radiation Therapy or Surgery in Treating Patients Receiving Chemotherapy for Bladder Cancer
Randomised Trial of Selective Bladder Preservation Against Radical Excision (Cystectomy) in Muscle Invasive T2/T3 Transitional Cell Carcinoma of the Bladder - Feasibility Study
- 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: Drugs used in chemotherapy, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether radiation therapy is more effective than surgery in treating patients with bladder cancer. PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared with surgery in treating patients with bladder cancer who are receiving chemotherapy.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| radiation therapy | Radiation | — | UNRESOLVED |
| therapeutic conventional surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm I
- description
- Patients undergo a radical cystectomy, including pelvic lymphadenectomy, between 4 and 6 weeks after initiating course 4 of chemotherapy.
- interventionNames
- Procedure: therapeutic conventional surgery
- type
- EXPERIMENTAL
- label
- Arm II
- description
- Patients with no visible residual tumor (cT0 or pT0) or residual but superficial tumor (pTa, pT1) undergo radiotherapy beginning within 4-6 weeks of day 1 of course 4 and continuing for 6.5 weeks.
- interventionNames
- Radiation: radiation therapy
Primary outcomes (4)
- measure
- Number of patients randomized over 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed transitional cell carcinoma (TCC) of the bladder * Clinical stage T2-T3, N0, M0 * No widespread carcinoma in situ (CIS) or CIS remote from muscle invasive tumor * No adenocarcinoma, squamous cell carcinoma (SCC), small cell carcinoma, or other variant histology * N.B. squamoid differentiation or mixed TCC/SCC allowed * No simultaneous upper tract, urethral, or prostatic urethral TCC * Direct prostatic urethral extension from bladder primary allowed if not involving prostatic stroma * Currently receiving 3 courses of gemcitabine hydrochloride-cisplatin or other protocol approved neoadjuvant chemotherapy regimen AND willing and fit to receive a 4th course according to study protocol PATIENT CHARACTERISTICS: * WHO performance status 0-1 * Hemoglobin \> 10 g/dL * WBC \> 3,000/mm³ * Platelet count \> 150,000/mm³ * Bilirubin \< 1.5 times upper limit of normal (ULN) * AST \< 1.5 times ULN * Alkaline phosphatase \< 1.5 times ULN * Not pregnant * Fit for radical cystectomy or radical radiotherapy * No prior malignancy within the past 5 years except superficial TCC or CIS * No untreated hydronephrosis * Patients with hydronephrosis are eligible if the kidney/ureter has been stented or nephrostomy has been inserted and renal function has been maintained * No contraindication to radical radiotherapy (e.g., inflammatory bowel disease, radiosensitivity syndrome, or severe diverticular disease) * No bilateral total hip replacements * No significant comorbid medical conditions that would interfere with administration of any protocol treatment PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior pelvic radiotherapy
References
Publications (2)
- RESULTParamasivan S, Huddart R, Hall E, Lewis R, Birtle A, Donovan JL. Key issues in recruitment to randomised controlled trials with very different interventions: a qualitative investigation of recruitment to the SPARE trial (CRUK/07/011). Trials. 2011 Mar 15;12:78. doi: 10.1186/1745-6215-12-78. PMID 21406089
- RESULTHuddart RA, Birtle A, Maynard L, Beresford M, Blazeby J, Donovan J, Kelly JD, Kirkbank T, McLaren DB, Mead G, Moynihan C, Persad R, Scrase C, Lewis R, Hall E. Clinical and patient-reported outcomes of SPARE - a randomised feasibility study of selective bladder preservation versus radical cystectomy. BJU Int. 2017 Nov;120(5):639-650. doi: 10.1111/bju.13900. Epub 2017 May 29. PMID 28453896