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Radiation Therapy, Chemotherapy, or Observation in Treating Patients With 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: NCT00002490
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : December 18, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with radiation therapy may kill more tumor cells. It is not known whether receiving either radiation therapy, chemotherapy, or observation is more effective for cancer of the bladder.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy, chemotherapy, or observation following tumor surgery in treating patients who have bladder cancer.

Condition or disease Intervention/treatment Phase
Bladder Cancer Biological: BCG vaccine Drug: mitomycin C Radiation: radiation therapy Phase 3

Detailed Description:


  • Compare the efficacy of adjuvant radical radiotherapy vs intravesical BCG or mitomycin vs observation alone after endoscopic resection in terms of the progression rate and survival of patients with stage I, grade 3 transitional cell carcinoma of the bladder.
  • Determine the toxicity of radical radiotherapy in these patients.
  • Determine the incidence of carcinoma in situ elsewhere in the bladder and its correlation with the subsequent clinical outcome of these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, extent of tumor (single tumor without carcinoma in situ (CIS) vs multiple tumors or CIS), and WHO performance status. Patients with a single tumor and no CIS are randomized to arm I or II. Patients with multiple tumors or CIS are randomized to arm II or III.

  • Arm I: Patients undergo observation only.
  • Arm II: Patients undergo radical radiotherapy 5 days a week for 6 weeks. Patients found to be node positive on CT scan may undergo pelvic irradiation and remain on study.
  • Arm III: Patients receive intravesical BCG or mitomycin (at the discretion of the physician) weekly for 6-12 weeks.

Patients on arms I and III are followed at 3 months after randomization. All patients are followed at 6, 9, and 12 months and then annually thereafter.

PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Primary Purpose: Treatment
Study Start Date : September 1991

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Diagnosis of transitional cell carcinoma of the bladder

    • Stage T1 Nx M0, grade 3 disease
    • No muscle invasion at base of tumor
    • Diagnosis of this stage made within the past 6 months

      • Earlier diagnosis of tumors with lower stage or grade allowed
      • No history of higher stage urothelial tumors
  • Presence of partial involvement of bladder with carcinoma in situ (CIS) or asymptomatic widespread CIS allowed

    • No widespread CIS causing severe symptoms
  • Prior complete transurethral resection of tumor with deep biopsy of underlying bladder wall required
  • Disease currently amenable to adjuvant radiotherapy, followed by cystoscopy with biopsies



  • Any age

Performance status:

  • WHO 0-2

Life expectancy:

  • Not specified


  • Not specified


  • Not specified


  • Not specified


  • No other prior or concurrent malignancy except nonmelanomatous skin cancer or cervical intraepithelial neoplasia


Biologic therapy:

  • No more than 1 prior adjuvant treatment with intravesical BCG


  • No more than 1 prior adjuvant treatment with intravesical chemotherapy

Endocrine therapy:

  • Not specified


  • See Disease Characteristics


  • See Disease Characteristics
  • Diathermic removal of associated small papillary growths allowed

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): NCT00002490

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United Kingdom
Middlesex Hospital- Meyerstein Institute
London, England, United Kingdom, WIT 3AA
Sponsors and Collaborators
Medical Research Council
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Study Chair: Stephen J. Harland, MD University College London Hospitals

Publications of Results:
Harland SJ: A randomised trial of radical radiotherapy in pT1G3 NXM0 bladder cancer (MRC BS06). [Abstract] J Clin Oncol 23 (Suppl 16): A-4505, 379s, 2005.

Layout table for additonal information Identifier: NCT00002490     History of Changes
Other Study ID Numbers: CDR0000077404
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: December 18, 2013
Last Verified: June 2001
Keywords provided by National Cancer Institute (NCI):
stage I bladder cancer
transitional cell carcinoma of the bladder
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
BCG Vaccine
Antibiotics, Antineoplastic
Antineoplastic Agents
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs