Radiation Therapy or Surgery in Treating Patients Receiving Chemotherapy for Bladder Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00867347
Recruitment Status : Unknown
Verified March 2009 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : March 23, 2009
Last Update Posted : July 12, 2011
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Bladder Cancer Procedure: therapeutic conventional surgery Radiation: radiation therapy Phase 3

Detailed Description:



  • 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 preservation.
  • 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1015 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: Randomised Trial of Selective Bladder Preservation Against Radical Excision (Cystectomy) in Muscle Invasive T2/T3 Transitional Cell Carcinoma of the Bladder - Feasibility Study
Study Start Date : December 2006
Estimated Primary Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Arm I

Patients undergo a radical cystectomy, including pelvic lymphadenectomy,

between 4 and 6 weeks after initiating course 4 of chemotherapy.

Procedure: therapeutic conventional surgery
Patients undergo radical cystectomy
Experimental: Arm II
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.
Radiation: radiation therapy
Patients undergo radiotherapy

Primary Outcome Measures :
  1. Number of patients randomized over 3 years
  2. Proportion of patients undergoing selective bladder preservation
  3. Proportion of patients undergoing radical cystectomy
  4. Overall survival

Secondary Outcome Measures :
  1. Compliance with randomized treatment
  2. Rate of salvage cystectomy after selective bladder preservation
  3. Toxicity as assessed by NCI CTCAE v3.0
  4. Quality of life as assessed by the QLQ-C30 v3.0 questionnaire
  5. Locoregional progression-free, metastasis-free, and overall survival

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00867347

United Kingdom
Institute of Cancer Research - Sutton
Sutton, England, United Kingdom, SM2 5PT
Sponsors and Collaborators
Institute of Cancer Research, United Kingdom
Principal Investigator: Robert A. Huddart, MD Royal Marsden NHS Foundation Trust

Publications of Results: Identifier: NCT00867347     History of Changes
Other Study ID Numbers: CDR0000633526
First Posted: March 23, 2009    Key Record Dates
Last Update Posted: July 12, 2011
Last Verified: March 2009

Keywords provided by National Cancer Institute (NCI):
transitional cell carcinoma of the bladder
stage II bladder cancer
stage III bladder cancer

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Carcinoma, Transitional Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type