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Radiation Therapy, Chemotherapy, or Observation in Treating Patients With Bladder Cancer

Sponsor
Medical Research Council (Other)
Overall Status
Completed
CT.gov ID
NCT00002490
Collaborator
(none)
1
Location

Study Details

Study Description

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
  • Biological: BCG vaccine
  • Drug: mitomycin C
  • Radiation: radiation therapy
 Phase 3

Detailed Description

OBJECTIVES:

  • 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.

Study Design

Study Type:
Interventional
Allocation:
Randomized
Primary Purpose:
Treatment
Official Title:
A RANDOMIZED TRIAL OF RADICAL RADIOTHERAPY IN pT1G3 NXM0 BLADDER CANCER
Study Start Date :
Sep 1, 1991

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    DISEASE CHARACTERISTICS:

    • 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

    PATIENT CHARACTERISTICS:
    Age:
    • Any age
    Performance status:
    • WHO 0-2
    Life expectancy:
    • Not specified
    Hematopoietic:
    • Not specified
    Hepatic:
    • Not specified
    Renal:
    • Not specified
    Other:
    • No other prior or concurrent malignancy except nonmelanomatous skin cancer or cervical intraepithelial neoplasia
    PRIOR CONCURRENT THERAPY:
    Biologic therapy:
    • No more than 1 prior adjuvant treatment with intravesical BCG
    Chemotherapy:
    • No more than 1 prior adjuvant treatment with intravesical chemotherapy
    Endocrine therapy:
    • Not specified
    Radiotherapy:
    • See Disease Characteristics
    Surgery:

    • See Disease Characteristics

    • Diathermic removal of associated small papillary growths allowed

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Middlesex Hospital- Meyerstein Institute London England United Kingdom WIT 3AA

    Sponsors and Collaborators

    • Medical Research Council

    Investigators

    • Study Chair: Stephen J. Harland, MD, University College London Hospitals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00002490
    Other Study ID Numbers:
    • CDR0000077404
    • MRC-BS06
    • EU-91019
    • ISRCTN65282717
    First Posted:
    Jan 27, 2003
    Last Update Posted:
    Dec 18, 2013
    Last Verified:
    Jun 1, 2001
    Keywords provided by , ,
    stage I bladder cancer
    transitional cell carcinoma of the bladder
    Additional relevant MeSH terms:
    Urinary Bladder Neoplasms
    Mitomycins
    Mitomycin
    BCG Vaccine

    Study Results

    No Results Posted as of Dec 18, 2013