Chemoradiotherapy for Recurrent T1G3 Bladder Cancer
1 other identifier
interventional
20
0 countries
N/A
Brief Summary
To evaluate the short term results of chemoradiation in case of T1G3 BC after BCG failure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Oct 2017
Typical duration for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 29, 2017
CompletedFirst Posted
Study publicly available on registry
September 6, 2017
CompletedStudy Start
First participant enrolled
October 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedSeptember 11, 2017
September 1, 2017
2.1 years
August 29, 2017
September 6, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
chemoradiotherapy
EXPERIMENTALChemoradiation in the form of cisplatin plus conformal radiotherapy 55GY/20 fractions which is biologically effective to 64GY/32 fractions fr
Interventions
chemoradiation in case of T1G3 BC after BCG failure.
Eligibility Criteria
You may qualify if:
- All patients with recurrent T1G3 bladder cancer after 6 doses of BCG consenting for chemoradiation and refusing radical cystectomy
You may not qualify if:
- Any patients with distant metastasis or positive LN on CT or MRI.
- Patients unfit for chemoradiation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related 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. doi: 10.1111/j.1464-410X.2007.06912.x.
PMID: 17552951BACKGROUNDSoloway MS, Sofer M, Vaidya A. Contemporary management of stage T1 transitional cell carcinoma of the bladder. J Urol. 2002 Apr;167(4):1573-83.
PMID: 11912367BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ahmed Moeen
Moeen3@yahoo.com
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Lecturer of Urology
Study Record Dates
First Submitted
August 29, 2017
First Posted
September 6, 2017
Study Start
October 1, 2017
Primary Completion
November 1, 2019
Study Completion
December 1, 2019
Last Updated
September 11, 2017
Record last verified: 2017-09