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

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).

Study Overview

• Status: Unknown
• Conditions: Urothelial Carcinoma Bladder; High-Risk Cancer
• Intervention / Treatment: Radiation: Adjuvant Radiotherapy

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11465
    • Recruiting
    • National Cancer Institute-Cairo University
    • Contact: Mohamed Zaghloul, MD; Phone Number: (20)01001720664; Email: mszagh@yahoo.com
    • Principal Investigator: Mohamed Zaghloul, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Adjuvant Radiotherapy; Irradiation of both the bladder tumor bed and pelvic lymph nodes using Intensity-Modulated Radiation-Therapy [IMRT] technique.	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]
No Intervention: Observation after radical Cystectomy; observation following radical cystectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local Control	2-year local-regional control rate	Two year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease Free Survival	2-year disease free survival rate	Two year

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Mohamed Zaghloul, MD, mszagh@yahoo.com

Publications and helpful links

General Publications

• 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. doi: 10.1016/0360-3016(92)90005-3.
• 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 Phase 2 Trial. JAMA Surg. 2018 Jan 17;153(1):e174591. doi: 10.1001/jamasurg.2017.4591. Epub 2018 Jan 17.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: February 2, 2021
• First Submitted That Met QC Criteria: February 2, 2021
• First Posted (Actual): February 5, 2021

Study Record Updates

• Last Update Posted (Actual): February 9, 2021
• Last Update Submitted That Met QC Criteria: February 8, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Radical Cystectomy; Neoadjuvant chemotherapy; Adjuvant Radiotherapy; Local Control; high risk Urothelial Carcinoma Bladder; Disease Free Survival (DFS)
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Urinary Bladder Diseases; Urinary Bladder Neoplasms; Carcinoma, Transitional Cell
• Other Study ID Numbers: Bladder-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No