Study Summary
This trial studies gemcitabine hydrochloride and cisplatin as a treatment for bladder cancer.
Eligible Conditions
- Bladder Cancer
- Bladder Cancer (Stage III)
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 7 Secondary · Reporting Duration: Up to 5 years
Day 84
Clinical response rate for patients harboring deleterious DDR gene alterations
At 3 years
Proportion of patients who are recurrence-free within the DDR mutated group who undergo the bladder sparing approach
Year 5
Bladder-intact survival in DDR-altered patients with < cT1 responses who selected the bladder sparing approach
Year 5
Overall survival
Recurrence-free survival
Up to 5 years
Pathologic response (pT0) rate at cystectomy in participants without DDR gene alterations
Proportion of patients in the bladder-sparing group who undergo local therapy
Within 3 years
The rate of cystectomies in patients with a DDR alteration and with a cT0/CIS/Ta response
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
2 Treatment Groups
Arm I (gemcitabine, cisplatin, bladder sparing)
1 of 2
Arm II (gemcitabine, cisplatin, cystectomy, chemoradiotherapy)
1 of 2
Experimental Treatment
271 Total Participants · 2 Treatment Groups
Primary Treatment: Radical Cystectomy · No Placebo Group · Phase 2
Arm I (gemcitabine, cisplatin, bladder sparing)Experimental Group · 4 Interventions: Pegfilgrastim, Cisplatin, Gemcitabine Hydrochloride, Conventional Surgery · Intervention Types: Biological, Drug, Drug, Procedure
Arm II (gemcitabine, cisplatin, cystectomy, chemoradiotherapy)Experimental Group · 5 Interventions: Pegfilgrastim, Cisplatin, Gemcitabine Hydrochloride, Radical Cystectomy, Chemoradiotherapy · Intervention Types: Biological, Drug, Drug, Procedure, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pegfilgrastim
FDA approved
Cisplatin
FDA approved
Gemcitabine
FDA approved
Conventional Surgery
2006
Completed Phase 3
~1000
Radical Cystectomy
2006
Completed Phase 2
~140
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,072 Previous Clinical Trials
41,128,647 Total Patients Enrolled
Alliance for Clinical Trials in OncologyLead Sponsor
503 Previous Clinical Trials
215,373 Total Patients Enrolled
Gopa Iyer, MDStudy ChairMemorial Sloan Kettering Cancer Center
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:A tumor that started in the cells that line the bladder and has spread to the muscles around the bladder is called muscle-invasive urothelial carcinoma
We have a set of 20 slides, each stained for 10 microns, that were taken from a diagnostic TUR specimen
A bladder tumor measuring 5 centimeters or less in size based on the observations by surgeons during a cystoscopy
This means that the patient must meet certain qualifications in order to be registered.
The patient is a good candidate for radical cystectomy surgery, as assessed by the surgeon.
No multifocal carcinoma in situ; a single focus is allowed.
No prior treatment with anti-PD-1 or anti PD-L1 antibodies, systemic chemotherapy, or BCG therapy in the past 5 years
is required
No radiation therapy is required to the bladder or prostate prior to treatment.
No evidence of locally advanced or metastatic disease.
You have a clinical stage T2-T4aN0/xM0 disease.
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Conditions
Cancer Related
Treatments