Back to results

Chemoradiotherapy for Recurrent T1G3 Bladder Cancer

Primary Purpose

Bladder Cancer

Status

Unknown status

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

chemoradiation

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring chemoradiation for, T1G3 BC

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

chemoradiotherapy

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03274284

First Posted

August 29, 2017

Last Updated

September 6, 2017

Sponsor

Assiut University

1. Study Identification

Unique Protocol Identification Number

NCT03274284

Brief Title

Chemoradiotherapy for Recurrent T1G3 Bladder Cancer

Official Title

Chemoradiotherapy for Recurrent T1G3 Bladder Cancer After BCG Failure

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Unknown status

Study Start Date

October 2017 (Anticipated)

Primary Completion Date

November 2019 (Anticipated)

Study Completion Date

December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bladder Cancer

Keywords

chemoradiation for, T1G3 BC

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

chemoradiotherapy

Arm Type

Experimental

Arm Description

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

Intervention Type

Combination Product

Intervention Name(s)

chemoradiation

Intervention Description

chemoradiation in case of T1G3 BC after BCG failure.

Primary Outcome Measure Information:

Title

Result of chemoradiation for recurrentT1G3 BC after BCG failure

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

moktar dawood

Phone

+201009442860

mokhtardawood@yahoo.com

First Name & Middle Initial & Last Name or Official Title & Degree

Diaa El Din Mohamed

Phone

+201001229936

Diaa-hameed@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ahmed Moeen

Organizational Affiliation

Moeen3@yahoo.com

Official's Role

Study Director

12. IPD Sharing Statement

Citations:

PubMed Identifier

17552951

Citation

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.

Results Reference

background

PubMed Identifier

11912367

Citation

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.

Results Reference

background

Learn more about this trial

Chemoradiotherapy for Recurrent T1G3 Bladder Cancer

We'll reach out to this number within 24 hrs