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

Overview

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).

Full Title of Study: “Prospective Randomized Trial of Adjuvant Radiotherapy Versus Observation After Radical Cystectomy in High Risk Urothelial Bladder Cancer”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2021

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.

Interventions

  • 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]

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Local Control
    • Time Frame: Two year
    • 2-year local-regional control rate

Secondary Measures

  • Disease Free Survival
    • Time Frame: Two year
    • 2-year disease free survival rate

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Cairo University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Mohamed s. Zaghloul, Professor – Cairo University
  • Overall Official(s)
    • Mohamed Zaghloul, MD, Principal Investigator, mszagh@yahoo.com
  • Overall Contact(s)
    • Mohamed Zaghloul, MD, (20)-01001720664, mszagh@yahoo.com

Citations Reporting on Results

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.

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