drugset / Trial / NCT01734798

Adjuvant Post-radical Cystectomy Treatment for Bladder Cancer

NCT01734798 ↗

Phase 3 Completed 198 enrolled Cairo University
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2002-12
Primary completion
2008-01
Completion
2012-11

Outcome

Met primary endpoint

paper for chemotherapy plus RT vs chemotherapy alone were 96% vs 69% (HR, 0.08; 95% CI, 0.02-0.39; P < .01) for LRFS PMID 29188298 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 70 mg/m2 Intravenous
Subject Gemcitabine Small molecule 1000 mg/m2 Intravenous