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Status unknownNCT03274284Updated Sep 11, 2017

Chemoradiotherapy for Recurrent T1G3 Bladder Cancer

A Phase 4 interventional study of chemoradiation in Bladder Cancer, sponsored by Assiut University. Status unknown. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2017-09-11.

Sponsored by Assiut University · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
40 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Bladder Cancer

Keywords

  • chemoradiation for
  • T1G3 BC
03

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Any patients with distant metastasis or positive LN on CT or MRI.
  • Patients unfit for chemoradiation
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • 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

Interventions

  • Combination productchemoradiation

    chemoradiation in case of T1G3 BC after BCG failure.

05

What researchers measure

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.

    Time frame: followup within two years

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • 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. PubMed 17552951 ↗
  • 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. PubMed 11912367 ↗
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Registry details

Key details

Study ID
NCT03274284
Lead sponsor
Assiut University
Responsible party
MokhtarDawood (Assistant Lecturer of Urology, Assiut University) — Principal investigator
First posted
Sep 6, 2017
Start date
Oct 2017 (estimated)
Primary completion
Nov 2019 (estimated)
Completion
Dec 2019 (estimated)
Last update
Sep 11, 2017

Study contacts

moktar dawood
Contact
mokhtardawood@yahoo.com
+201009442860
Diaa El Din Mohamed
Contact
Diaa-hameed@hotmail.com
+201001229936
Ahmed Moeen
study director · Moeen3@yahoo.com

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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