Adjuvant Post-radical Cystectomy Treatment for Bladder Cancer
Overview
- Phase
- Phase 3
- Intervention
- Radiation
- Conditions
- Locally Advanced Bladder Cancer
- Sponsor
- Cairo University
- Enrollment
- 198
- Locations
- 1
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief 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.
Investigators
Mohamed s. Zaghloul
Professor of Radiation Oncology
Cairo University
Eligibility 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
Arms & Interventions
Arm 1
post-operative radiotherapy will be done in locally advanced bladder cancer patients (P3b, P4a, G3 and / or LN positive patients) after radical cystectomy Dose of Radiotherapy: 45 Gray Gy/30 fractions/3 weeks
Intervention: Radiation
Arm 2
adjuvant chemotherapy (gemcitabine and cisplatin) in addition to post operative radiotherapy in locally advanced bladder cancer patients (P3b, P4a, G3 and / or LN positive patients) after radical cystectomy
Intervention: Radiotherapy and Drug
Arm 3
Adjuvant chemotherapy alone in locally advanced bladder cancer patients (P3b, P4a, G3 and / or LN positive patients) after radical cystectomy
Intervention: gemcitabine and cisplatin
Outcomes
Primary Outcomes
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
Time Frame: Five-year overall and disease-free survival.
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.
Secondary Outcomes
- comparison of the Local recurrence rate in the three Arms(Five year local pelvic control rate)