Adjuvant Post-radical Cystectomy Treatment for Bladder Cancer

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Radical Cystectomy is still the standard treatment in muscle-invasive Bladder cancer. Local recurrence is still the major cause of failure together with distant metastasis. postoperative radiotherapy succeeded to decrease the local recurrence and hence improved the overall survival. Adjuvant chemotherapy has also improved the survival in different studies. This study is performed to test the efficacy and toxicity of adding the two modalities together compared to each modality alone.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cairo University
• Treatments: Cisplatin; Gemcitabine

Criteria

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