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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2022-12-01

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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High-Risk Cancer Urothelial Carcinoma Bladder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Adjuvant Radiotherapy

Irradiation of both the bladder tumor bed and pelvic lymph nodes using Intensity-Modulated Radiation-Therapy \[IMRT\] technique.

Group Type ACTIVE_COMPARATOR

Adjuvant Radiotherapy

Intervention Type RADIATION

Irradiation of both the bladder tumor bed and pelvic lymph nodes using Intensity-Modulated Radiation-Therapy (IMRT) technique. (\[50Gy in 25 fractions conventional fractionation including tumor bed \& pelvic lymph nodes\]

Observation after radical Cystectomy

observation following radical cystectomy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Adjuvant Radiotherapy

Irradiation of both the bladder tumor bed and pelvic lymph nodes using Intensity-Modulated Radiation-Therapy (IMRT) technique. (\[50Gy in 25 fractions conventional fractionation including tumor bed \& pelvic lymph nodes\]

Intervention Type RADIATION

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No