Locally Advanced Bladder Cancer Clinical Trial
Official title:
Adjuvant Post-radical Cystectomy Treatment for Bladder Cancer
| Verified date | November 2012 |
| Source | Cairo University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Egypt: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 198 |
| Est. completion date | November 2012 |
| Est. primary completion date | January 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 70 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Egypt | National cancer Institute-Cairo University | Cairo |
| Lead Sponsor | Collaborator |
|---|---|
| Cairo University |
Egypt,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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. | Five-year overall and disease-free survival. | Yes |
| Secondary | comparison of the Local recurrence rate in the three Arms | 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. | Five year local pelvic control rate | Yes |