Gemcitabine for Bladder Cancer

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
University Health Network, Toronto, CanadaBladder Cancer+1 MoreGemcitabine - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is looking at the feasibility of conducting a larger clinical trial to see if neoadjuvant chemotherapy can help improve survival for people with UTUC.

Eligible Conditions
  • Bladder Cancer

Treatment Effectiveness

Effectiveness Progress

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

Study Objectives

3 Primary · 3 Secondary · Reporting Duration: 36 months

24 months
Feasibility of enrolling cT1-4N0 M0 UTUC patients in a randomized trial of neoadjuvant chemotherapy versus standard of care by assessing pilot trial recruitment rates
Number of patients approached per site per month
Number of patients randomized per site per month
Site-specific enrolment rate
36 months
Disease-free survival (DFS)
Rate of complete pathologic response

Trial Safety

Safety Progress

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

Trial Design

2 Treatment Groups

Adjuvant Chemotherapy Arm (Standard of Care)
1 of 2
Neoadjuvant Chemotherapy Arm
1 of 2

Active Control

Experimental Treatment

14 Total Participants · 2 Treatment Groups

Primary Treatment: Gemcitabine · No Placebo Group · Phase 3

Neoadjuvant Chemotherapy ArmExperimental Group · 2 Interventions: Gemcitabine, Cisplatin · Intervention Types: Drug, Drug
Adjuvant Chemotherapy Arm (Standard of Care)ActiveComparator Group · 3 Interventions: Gemcitabine, Carboplatin, Cisplatin · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine
FDA approved
Cisplatin
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 36 months

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,386 Previous Clinical Trials
471,980 Total Patients Enrolled
Bladder Cancer CanadaUNKNOWN
1 Previous Clinical Trials
2 Total Patients Enrolled
Girish Kulkarni, MDPrincipal InvestigatorUniversity Health Network - Princess Margaret Hospital

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

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Frequently Asked Questions

Has the FDA given Gemcitabine the green light?

"Gemcitabine's safety is based on Phase 3 trial data, which suggests that the drug is efficacious and has undergone multiple rounds of safety testing." - Anonymous Online Contributor

Unverified Answer

What conditions does Gemcitabine typically help?

"Commonly, advanced endometrial cancer is treated with Gemcitabine. However, this chemotherapy drug can also be effective for treating melanoma, lymphoma, non-hodgkin, and advanced sarcoma." - Anonymous Online Contributor

Unverified Answer

Are you still looking for new test subjects for this clinical trial?

"Yes, as of 4/12/2022 this study is still recruiting patients, according to the listing on clinicaltrials.gov. This particular trial was first advertised on 2/8/2021." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.