Urothelial Carcinoma Bladder Clinical Trial
Official title:
Prospective Randomized Trial of Adjuvant Radiotherapy Versus Observation After Radical Cystectomy in High Risk Urothelial Bladder Cancer
This is a prospective randomized clinical trial in high risk urothelial bladder cancer to compare adjuvant radiotherapy versus observation after radical cyctectomy. This is to clarify the benefit of adjuvant radiotherapy while limiting gastrointestinal toxicities for patients with pathological high-risk bladder cancer through assessing locoregional control (LRC).
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 1, 2022 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: Patient with muscle-invasive urothelial cancer, who received neoadjuvant chemotherapy followed by radical cystectomy and urinary diversion with negative safety margin and belongs to one or more of the categories: - = 18 years old. - PT3 or PT4a tumors. - Grade 3 urothelial cancer. - Positive infiltration of the dissected pelvic lymph nodes. Exclusion Criteria: - Residual tumors upon cystectomy. - Previous pelvic irradiation. - Non-urothelial bladder tumors. - WHO performance status above 2. - Any psychological, familial, sociological or geographical condition that hamper compliance with the study and/ or follow up schedule. |
Country | Name | City | State |
---|---|---|---|
Egypt | National Cancer Institute-Cairo University | Cairo |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
Zaghloul MS, Awwad HK, Akoush HH, Omar S, Soliman O, el Attar I. Postoperative radiotherapy of carcinoma in bilharzial bladder: improved disease free survival through improving local control. Int J Radiat Oncol Biol Phys. 1992;23(3):511-7. — View Citation
Zaghloul MS, Christodouleas JP, Smith A, Abdallah A, William H, Khaled HM, Hwang WT, Baumann BC. Adjuvant Sandwich Chemotherapy Plus Radiotherapy vs Adjuvant Chemotherapy Alone for Locally Advanced Bladder Cancer After Radical Cystectomy: A Randomized Pha — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Local Control | 2-year local-regional control rate | Two year | |
Secondary | Disease Free Survival | 2-year disease free survival rate | Two year |
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