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NCT03274284 Clinical Trial

Chemoradiotherapy for Recurrent T1G3 Bladder Cancer

Bladder Cancer Clinical Trial

Official title:
Chemoradiotherapy for Recurrent T1G3 Bladder Cancer After BCG Failure

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03274284
Other study ID # Bl Cancer
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received August 29, 2017
Last updated September 6, 2017
Start date October 2017
Est. completion date December 2019

Study information
Verified date September 2017
Source Assiut University
Contact moktar dawood
Phone +201009442860
Email mokhtardawood@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To evaluate the short term results of chemoradiation in case of T1G3 BC after BCG failure.

Description:

Non- muscle invasive bladder cancer (NMIBC) is a heterogeneous group of cancers. For most urologists the treatment of T1G3 tumor poses a dilemma of management.The spectrum of clinical behavior includes; T1 lesions that will not progress however T1G3 may be potentially lethal, associated with metastatic disease at the time of presentation.

The major goal of treatment for T1G3 BC should be bladder preservation whenever possible.

Intravesical therapy with Bacille Calmette Guerin (BCG) may decrease the recurrence rate by compared with transurethral resection of bladder tumor (TURBT) alone.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 20
Est. completion date December 2019
Est. primary completion date November 2019
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility Inclusion Criteria:

- All patients with recurrent T1G3 bladder cancer after 6 doses of BCG consenting for chemoradiation and refusing radical cystectomy

Exclusion Criteria:

- Any patients with distant metastasis or positive LN on CT or MRI.

- Patients unfit for chemoradiation

Study Design

Related Conditions & MeSH terms

Intervention

Combination Product:
• chemoradiation
chemoradiation in case of T1G3 BC after BCG failure.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Assiut University

References & Publications (2)

Lambert EH, Pierorazio PM, Olsson CA, Benson MC, McKiernan JM, Poon S. The increasing use of intravesical therapies for stage T1 bladder cancer coincides with decreasing survival after cystectomy. BJU Int. 2007 Jul;100(1):33-6. — View Citation

Soloway MS, Sofer M, Vaidya A. Contemporary management of stage T1 transitional cell carcinoma of the bladder. J Urol. 2002 Apr;167(4):1573-83. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Result of chemoradiation for recurrentT1G3 BC after BCG failure treatment of 20 patients with recurrent T1G3
BC by chemoradiation to see efficacy and safety .and to reduce the number of recurrent cases and improve survival.		 followup within two years
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