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Randomised Trial of Selective Bladder Preservation Against Radical Excision (Cystectomy) in Muscle Invasive T2/T3 Transitional Cell Carcinoma of the Bladder - Feasibility Study

Phase 3
18 Years
Open (Enrolling)
Bladder Cancer

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Trial Information

Randomised Trial of Selective Bladder Preservation Against Radical Excision (Cystectomy) in Muscle Invasive T2/T3 Transitional Cell Carcinoma of the Bladder - Feasibility Study



- To determine the feasibility and patient acceptability of radical cystectomy vs
selective bladder preservation (SBP) after neoadjuvant chemotherapy in patients with
muscle-invasive transitional cell carcinoma of the bladder.

- To determine compliance rates of patients with their assigned treatments.

- To determine if bladder preservation is equivalent to radical cystectomy, in terms of
overall survival, in responders to neoadjuvant chemotherapy.


- To compare the overall survival of patients receiving SBP vs radical cystectomy.

- To determine the rate of salvage cystectomy in patients undergoing bladder

- To determine and compare the toxicity of treatment in both arms.

- To determine and compare quality of life of patients treated with these regimens.

- To compare locoregional progression-free and metastasis-free survival of patients
treated with these regimens.

OUTLINE: This is a multicenter study. Patients are stratified according to cancer center and
randomized to 1 of 2 treatment arms. Patients are assessed after completion of 3 courses of
pre-study neoadjuvant chemotherapy. Patients with poor response (≥ pT2, residual pT2,
macroscopic invasive tumor) undergo immediate radical cystectomy (within 6 weeks fo
completing chemotherapy). Patients* with responsive disease (≤ pT1 tumor or macroscopically
normal bladder) proceed to course 4 of chemotherapy (on-study) followed by treatment
according to randomization arm.

NOTE: *Patients with a clear bladder or those who are unsure of their histological results
prior to course 4 also proceed to chemotherapy.

- Course 4 of neoadjuvant chemotherapy: Patients receive gemcitabine hydrochloride IV
over 30 minutes on days 1 and 8 and cisplatin IV over 4 hours on day 1.

- Arm I (radical cystectomy): Patients undergo a radical cystectomy, including pelvic
lymphadenectomy, between 4 and 6 weeks after initiating course 4 of chemotherapy.

- Arm II (selective bladder preservation): 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.

Health-related quality of life is assessed periodically.

After completion of study treatment, patients are followed periodically for up to 5 years.

Inclusion Criteria


- 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


- 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


- See Disease Characteristics

- No prior pelvic radiotherapy

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Number of patients randomized over 3 years

Safety Issue:


Principal Investigator

Robert A. Huddart, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Royal Marsden NHS Foundation Trust


United States: Federal Government

Study ID:




Start Date:

December 2006

Completion Date:

Related Keywords:

  • Bladder Cancer
  • transitional cell carcinoma of the bladder
  • stage II bladder cancer
  • stage III bladder cancer
  • Urinary Bladder Neoplasms
  • Carcinoma, Transitional Cell