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

Primary Purpose

High-Risk Cancer, Urothelial Carcinoma Bladder

Status

Unknown status

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Adjuvant Radiotherapy

About this trial

This is an interventional treatment trial for High-Risk Cancer focused on measuring Adjuvant Radiotherapy, Neoadjuvant chemotherapy, Radical Cystectomy, high risk Urothelial Carcinoma Bladder, Local Control, Disease Free Survival (DFS)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

National Cancer Institute-Cairo UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Adjuvant Radiotherapy

Observation after radical Cystectomy

Arm Description

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

observation following radical cystectomy

Outcomes

Primary Outcome Measures

Local Control

2-year local-regional control rate

Secondary Outcome Measures

Disease Free Survival

2-year disease free survival rate

Full Information

NCT ID

NCT04740866

First Posted

February 2, 2021

Last Updated

February 8, 2021

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT04740866

Brief Title

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

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Unknown status

Study Start Date

August 1, 2018 (Actual)

Primary Completion Date

December 31, 2021 (Anticipated)

Study Completion Date

December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

High-Risk Cancer, Urothelial Carcinoma Bladder

Keywords

Adjuvant Radiotherapy, Neoadjuvant chemotherapy, Radical Cystectomy, high risk Urothelial Carcinoma Bladder, Local Control, Disease Free Survival (DFS)

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Adjuvant Radiotherapy

Arm Type

Active Comparator

Arm Description

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

Arm Title

Observation after radical Cystectomy

Arm Type

No Intervention

Arm Description

observation following radical cystectomy

Intervention Type

Radiation

Intervention Name(s)

Adjuvant Radiotherapy

Intervention Description

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]

Primary Outcome Measure Information:

Title

Local Control

Description

2-year local-regional control rate

Time Frame

Two year

Secondary Outcome Measure Information:

Title

Disease Free Survival

Description

2-year disease free survival rate

Time Frame

Two year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mohamed Zaghloul, MD

Phone

(20)-01001720664

mszagh@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mohamed Zaghloul, MD

Organizational Affiliation

mszagh@yahoo.com

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Cancer Institute-Cairo University

City

Cairo

ZIP/Postal Code

11465

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mohamed Zaghloul, MD

Phone

(20)01001720664

mszagh@yahoo.com

First Name & Middle Initial & Last Name & Degree

Mohamed Zaghloul, MD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

1612951

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.

Results Reference

result

PubMed Identifier

29188298

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.

Results Reference

result

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

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