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Chemoradiotherapy for Recurrent T1G3 Bladder Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03274284
Recruitment Status : Unknown
Verified September 2017 by MokhtarDawood, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : September 6, 2017
Last Update Posted : September 11, 2017
Sponsor:
Information provided by (Responsible Party):
MokhtarDawood, Assiut University

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

Condition or disease Intervention/treatment Phase
Bladder Cancer Combination Product: chemoradiation Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Chemoradiotherapy for Recurrent T1G3 Bladder Cancer After BCG Failure
Estimated Study Start Date : October 2017
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arm Intervention/treatment
Experimental: chemoradiotherapy
Chemoradiation in the form of cisplatin plus conformal radiotherapy 55GY/20 fractions which is biologically effective to 64GY/32 fractions fr
Combination Product: chemoradiation
chemoradiation in case of T1G3 BC after BCG failure.




Primary Outcome Measures :
  1. Result of chemoradiation for recurrentT1G3 BC after BCG failure [ Time Frame: 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03274284


Contacts
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Contact: moktar dawood +201009442860 mokhtardawood@yahoo.com
Contact: Diaa El Din Mohamed +201001229936 Diaa-hameed@hotmail.com

Sponsors and Collaborators
Assiut University
Investigators
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Study Director: Ahmed Moeen Moeen3@yahoo.com

Publications:
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Responsible Party: MokhtarDawood, Assistant Lecturer of Urology, Assiut University
ClinicalTrials.gov Identifier: NCT03274284    
Other Study ID Numbers: Bl Cancer
First Posted: September 6, 2017    Key Record Dates
Last Update Posted: September 11, 2017
Last Verified: September 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by MokhtarDawood, Assiut University:
chemoradiation for
T1G3 BC
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases