Chemoradiotherapy for Recurrent T1G3 Bladder Cancer

NCT ID: NCT03274284

Last Updated: 2017-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-31

Study Completion Date

2019-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Bladder Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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chemoradiotherapy

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

Group Type EXPERIMENTAL

chemoradiation

Intervention Type COMBINATION_PRODUCT

chemoradiation in case of T1G3 BC after BCG failure.

Interventions

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chemoradiation

chemoradiation in case of T1G3 BC after BCG failure.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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MokhtarDawood

Assistant Lecturer of Urology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed Moeen

Role: STUDY_DIRECTOR

[email protected]

Central Contacts

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moktar dawood

Role: CONTACT

+201009442860

Diaa El Din Mohamed

Role: CONTACT

+201001229936

References

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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. doi: 10.1111/j.1464-410X.2007.06912.x.

Reference Type BACKGROUND
PMID: 17552951 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11912367 (View on PubMed)

Other Identifiers

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Bl Cancer

Identifier Type: -

Identifier Source: org_study_id

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