Adjuvant Post-radical Cystectomy Treatment for Bladder Cancer

Study 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.

Official Title
-----------------
Adjuvant Post-radical Cystectomy Treatment for Bladder Cancer

Conditions
-----------------
Locally Advanced Bladder Cancer

Intervention / Treatment
-----------------
* Radiation: Radiation
* Drug: gemcitabine and cisplatin
* Other: Radiotherapy and Drug


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>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 | Radiation: Radiation<br> <br> |
| Experimental: Arm 2<br>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 | Other: Radiotherapy and Drug<br> <br> |
| Experimental: Arm 3<br>Adjuvant chemotherapy alone in locally advanced bladder cancer patients (P3b, P4a, G3 and / or LN positive patients) after radical cystectomy | Drug: gemcitabine and cisplatin<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
locally advanced bladder cancer, Postoperative radiotherapy, Adjuvant chemotherapy, Radical Cystectomy