Adjuvant Post-radical Cystectomy Treatment for Bladder Cancer
18 Years
70 Years
Both
Locally Advanced Bladder Cancer
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:
Interventional
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:
Yes
Authority:
Egypt: Institutional Review Board
Study ID:
Bladder-02
NCT ID:
NCT01734798
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
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