Clinical trial NCT04740866: Adjuvant Radiotherapy Versus Observation After Radical Cystectomy in High Risk Urothelial Bladder Cancer
Official title: Prospective Randomized Trial of Adjuvant Radiotherapy Versus Observation After Radical Cystectomy in High Risk Urothelial Bladder Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: High-Risk Cancer
Urothelial Carcinoma Bladder
Keywords: Adjuvant Radiotherapy
Neoadjuvant chemotherapy
Radical Cystectomy
high risk Urothelial Carcinoma Bladder
Local Control
Disease Free Survival (DFS)
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-02-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Local Control
timeFrame: Two year
Secondary outcomes:
measure: Disease Free Survival
timeFrame: Two year
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National Cancer Institute-Cairo University
Study officials:
affiliation: mszagh@yahoo.com
name: Mohamed Zaghloul, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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 Phase 2 Trial. JAMA Surg. 2018 Jan 17;153(1):e174591. doi: 10.1001/jamasurg.2017.4591. Epub 2018 Jan 17.