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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04740866
Other study ID # Bladder-03
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 1, 2018
Est. completion date December 1, 2022

Study information

Verified date February 2021
Source Cairo University
Contact Mohamed Zaghloul, MD
Phone (20)-01001720664
Email mszagh@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


Description:

This is prospective randomized trial in high risk urothelial bladder cancer that includes 2 arms. The randomization will be done by permuted block method to 2 equal comparable groups. The total number of subjects will be 50 in each arm (Total=100 subjects). This study include patients who may receive neoadjuvant chemotherapy [Gemcitabine+Cisplatin]) or not. Arm (1) in this study (N=50) will received irradiation of both the bladder tumor bed and pelvic lymph nodes using IMRT technique. For Arm (2) (N=50) will undergo observation following radical cystectomy.


Recruitment information / eligibility

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.

Study Design


Intervention

Radiation:
Adjuvant Radiotherapy
Irradiation of both the bladder tumor bed and pelvic lymph nodes using Intensity-Modulated Radiation-Therapy (IMRT) technique. ([50Gy in 25 fractions conventional fractionation including tumor bed & pelvic lymph nodes]

Locations

Country Name City State
Egypt National Cancer Institute-Cairo University Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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

Outcome

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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