Chemoradiotherapy for Recurrent T1G3 Bladder Cancer

Assiut University

Status and phase: Unknown; Phase 4

Conditions: Bladder Cancer

Treatments: Combination Product: chemoradiation

Study type: Interventional

Funder types: Other

Identifiers

NCT03274284

Bl Cancer

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

chemoradiotherapy

Experimental group

Description:

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

Treatment:

Combination Product: chemoradiation