Adjuvant Radiotherapy Versus Observation After Radical Cystectomy in High Risk Urothelial Bladder Cancer

Urothelial Carcinoma Bladder Clinical Trial

Official title:

Prospective Randomized Trial of Adjuvant Radiotherapy Versus Observation After Radical Cystectomy in High Risk Urothelial Bladder Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04740866
• Other study ID #: Bladder-03
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Carcinoma, Transitional Cell
• High-Risk Cancer
• Urinary Bladder Neoplasms
• Urothelial Carcinoma Bladder

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