Transurethral Resection of Bladder Tumor for Bladder Cancer

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Bladder Cancer+4 MoreTransurethral Resection of Bladder Tumor - Procedure
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing how well chemotherapy and radiation therapy work with or without atezolizumab in treating patients with localized muscle invasive bladder cancer.

Eligible Conditions
  • Bladder Cancer
  • Stage II Bladder Cancer
  • Stage IIIA Bladder Cancer
  • Stage III Bladder Cancer

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: Up to 5 years

At 18 weeks
Biopsy response
Year 5
Quality of life
Year 5
Cancer-specific survival
Year 5
Overall survival (OS)
Year 5
Progression-free survival
Year 5
Metastasis-free survival
Day 90
Modified bladder intact event-free survival (mBI-EFS)
Year 5
Bladder intact event-free survival (BI-EFS)
Week 18
Complete response duration
Up to 5 years
Treatment interactions

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Arm I (RT, chemotherapy)
1 of 2
Arm II (RT, chemotherapy, atezolizumab)
1 of 2

Active Control

Experimental Treatment

475 Total Participants · 2 Treatment Groups

Primary Treatment: Transurethral Resection of Bladder Tumor · No Placebo Group · Phase 3

Arm II (RT, chemotherapy, atezolizumab)Experimental Group · 13 Interventions: Atezolizumab, Transurethral Resection of Bladder Tumor, Cystoscopy, Magnetic Resonance Imaging, Biopsy of Bladder, Computed Tomography, Cisplatin, Fluorouracil, Gemcitabine, Mitomycin, Quality-of-Life Assessment, Radiation Therapy, Survey Administration · Intervention Types: Drug, Procedure, Procedure, Procedure, Procedure, Procedure, Drug, Drug, Drug, Drug, Other, Radiation, Other
Arm I (RT, chemotherapy)ActiveComparator Group · 12 Interventions: Transurethral Resection of Bladder Tumor, Cystoscopy, Magnetic Resonance Imaging, Biopsy of Bladder, Computed Tomography, Cisplatin, Fluorouracil, Gemcitabine, Mitomycin, Quality-of-Life Assessment, Radiation Therapy, Survey Administration · Intervention Types: Procedure, Procedure, Procedure, Procedure, Procedure, Drug, Drug, Drug, Drug, Other, Radiation, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
FDA approved
Cystoscopy
2016
Completed Phase 4
~800
Magnetic Resonance Imaging
2017
Completed Phase 2
~1100
Computed Tomography
2017
Completed Phase 2
~3410
Chloride ion
Not yet FDA approved
Fluorouracil
FDA approved
Gemcitabine
FDA approved
Mitomycin
FDA approved
Radiation Therapy
2005
Completed Phase 3
~7010

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,073 Previous Clinical Trials
41,138,433 Total Patients Enrolled
Parminder SinghPrincipal InvestigatorSouthwest Oncology Group
1 Previous Clinical Trials
2 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Patient required review of pre-RT planning must occur within 14 days of initial registration.
You are planning to receive one of the protocol specified chemotherapy regimens.
Patients must have had a surgery and/or intravesical therapy within the past 12 months.
You are not eligible for this study if you are under 18 years of age.
Patients must have histologically proven, T2-T4a N0M0 urothelial carcinoma of the bladder within 120 days prior to randomization and no intervening treatment between the histologic proof and randomization
Patients must undergo radiological staging within 70 days prior to randomization
Patients with hydronephrosis are eligible if they have unilateral hydronephrosis and kidney function meets criteria specified.