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

Sponsor

Cairo University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04740866

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
High-Risk Cancer Urothelial Carcinoma Bladder	Radiation: Adjuvant Radiotherapy	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 1, 2018

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Local Control [Two year]
2-year local-regional control rate

Secondary Outcome Measures

Disease Free Survival [Two year]
2-year disease free survival rate

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.