Search / Trial NCT00002490

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

Launched by MEDICAL RESEARCH COUNCIL · Jan 26, 2003

Trial Information

Current as of December 06, 2024

Completed

Keywords

Stage I Bladder Cancer Transitional Cell Carcinoma Of The Bladder

ClinConnect Summary

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 t...

Gender

ALL

Eligibility criteria

  • 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

Trial Officials

Stephen J. Harland, MD

Study Chair

University College London Hospitals

About Medical Research Council

The Medical Research Council (MRC) is a prominent UK-based organization dedicated to advancing medical research and improving health outcomes through innovative scientific inquiry. As a leading sponsor of clinical trials, the MRC fosters collaboration among researchers, healthcare professionals, and industry partners to facilitate cutting-edge studies that address critical health challenges. With a strong emphasis on evidence-based research, the MRC supports a diverse portfolio of clinical trials aimed at translating scientific discoveries into practical applications, ultimately enhancing patient care and public health. Their commitment to rigorous ethical standards and regulatory compliance ensures the integrity and reliability of the research they sponsor.

Locations

London, England, United Kingdom

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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