NCT04740866

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2018

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

February 2, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 5, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

February 9, 2021

Status Verified

February 1, 2021

Enrollment Period

3.4 years

First QC Date

February 2, 2021

Last Update Submit

February 8, 2021

Conditions

High-Risk CancerUrothelial Carcinoma Bladder

Keywords

Adjuvant RadiotherapyNeoadjuvant chemotherapyRadical Cystectomyhigh risk Urothelial Carcinoma BladderLocal ControlDisease Free Survival (DFS)

Outcome Measures

Primary Outcomes (1)

  • Local Control

    2-year local-regional control rate

    Two year

Secondary Outcomes (1)

  • Disease Free Survival

    Two year

Study Arms (2)

Adjuvant Radiotherapy

ACTIVE COMPARATOR

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

Radiation: Adjuvant Radiotherapy

Observation after radical Cystectomy

NO INTERVENTION

observation following radical cystectomy

Interventions

Adjuvant RadiotherapyRADIATION

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

Adjuvant Radiotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Institute-Cairo University

Cairo, 11465, Egypt

RECRUITING

Related Publications (2)

  • 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.

    PMID: 1612951RESULT

  • 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.

    PMID: 29188298RESULT

MeSH Terms

Interventions

Radiotherapy, Adjuvant

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsRadiotherapy

Study Officials

  • Mohamed Zaghloul, MD

    mszagh@yahoo.com

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Zaghloul, MD

CONTACT

(20)-01001720664mszagh@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 2, 2021

First Posted

February 5, 2021

Study Start

August 1, 2018

Primary Completion

December 31, 2021

Study Completion

December 1, 2022

Last Updated

February 9, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)