Adjuvant Post-radical Cystectomy Treatment for Bladder Cancer

Phase 3

Completed

• Conditions: Locally Advanced Bladder Cancer
• Interventions: Drug: gemcitabine and cisplatin; Radiation: Radiation; Other: Radiotherapy and Drug

• Registration Number: NCT01734798
• Lead Sponsor: Cairo University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-12
• Primary Completion: 2008-01
• Status Verified: 2012-11
• Study Completion: 2012-11
• Study First Submitted: 2012-11-19
• Study First Submitted QC: 2012-11-22
• Last Update Submitted: 2012-11-22
• Study First Posted: 2012-11-28
• Last Update Posted: 2012-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 198

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 3	gemcitabine and cisplatin	Adjuvant chemotherapy alone in locally advanced bladder cancer patients (P3b, P4a, G3 and / or LN positive patients) after radical cystectomy
Arm 1	Radiation	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
Arm 2	Radiotherapy and Drug	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

Primary Outcome Measures

Name	Time	Method
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	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 Outcome Measures

Name	Time	Method
comparison of the Local recurrence rate in the three Arms	Five year local pelvic control rate	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.

Trial Locations

Locations (1)

National cancer Institute-Cairo University; 🇪🇬 Cairo, Egypt