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Adjuvant Post-radical Cystectomy Treatment for Bladder Cancer

Phase 3
18 Years
70 Years
Not Enrolling
Locally Advanced Bladder Cancer

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Trial Information

Adjuvant Post-radical Cystectomy Treatment for Bladder Cancer

Inclusion Criteria:

- Patients not more than 70 years old.

- Radical cystectomy performed within 42 days with no microscopic or macroscopic
residual after surgery (negative surgical safety margins)

- Having one or more of the risk factors ( P3b,P4a,G3 and /or positive LN)

- ECOG Performance Scale (0-2).

- Adequate liver functions.

- Adequate renal function serum (creatinine < 1.5 mg).

- No evidence of distant metastasis or other malignancy.

Exclusion Criteria:

- patients who received radiotherapy or chemotherapy prior to radical cystectomy

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Comparison of the disease-free survival and overall survival of post-operative radiotherapy , adjuvant chemotherapy and the combined modalities [radiotherapy and chemotherapy] after radical cystectomy

Outcome Description:

Regular follow up is performed every 2 months in the first 2 years postcystectomy and every 6 months thereafter. Periodical CT pelvis is performed every 6 months in the first 2 years and yearly thereafter. The other appropriate radiological studies are performed in response to patients' symptoms and signs. Treatment side effects (immediate and late) are reported in each follow up visit.

Outcome Time Frame:

Five-year overall and disease-free survival.

Safety Issue:



Egypt: Institutional Review Board

Study ID:




Start Date:

December 2002

Completion Date:

November 2012

Related Keywords:

  • Locally Advanced Bladder Cancer
  • locally advanced bladder cancer
  • Postoperative radiotherapy
  • Adjuvant chemotherapy
  • Radical Cystectomy
  • Urinary Bladder Neoplasms