Chemoradiotherapy for Recurrent T1G3 Bladder Cancer

Phase 4

• Conditions: Bladder Cancer
• Interventions: Combination Product: chemoradiation

• Registration Number: NCT03274284
• Lead Sponsor: Assiut University

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2017-08-29
• Status Verified: 2017-09
• Study First Submitted QC: 2017-09-05
• Study First Posted: 2017-09-06
• Last Update Submitted: 2017-09-06
• Last Update Posted: 2017-09-11
• Study Start: 2017-10
• Primary Completion: 2019-11
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

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Exclusion Criteria

• Any patients with distant metastasis or positive LN on CT or MRI.
• Patients unfit for chemoradiation

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
chemoradiotherapy	chemoradiation	Chemoradiation in the form of cisplatin plus conformal radiotherapy 55GY/20 fractions which is biologically effective to 64GY/32 fractions fr

Primary Outcome Measures

Name	Time	Method
Result of chemoradiation for recurrentT1G3 BC after BCG failure	followup within two years	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.