Ignite Creation Date:
2024-05-05 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00445601
Status:
COMPLETED
Last Update Posted:
2020-01-18
First Post:
2007-03-07
Brief Title:
S0337 Gemcitabine After Surgery in Treating Patients With Newly Diagnosed or Recurrent Bladder Cancer
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
A Phase III Blinded Study of Immediate Post TURBT Instillation of Gemcitabine Versus Saline in Patients With Newly Diagnosed or Occasionally Recurring Grade III Superficial Bladder Cancer
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy such as gemcitabine work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving gemcitabine directly into the bladder after surgery may kill more tumor cells It is not yet known whether giving gemcitabine directly into the bladder is more effective than a placebo in treating bladder cancer
PURPOSE This randomized phase III trial is studying gemcitabine to see how well it works when given directly into the bladder compared with a placebo after surgery in treating patients with newly diagnosed or recurrent bladder cancer
PURPOSE This randomized phase III trial is studying gemcitabine to see how well it works when given directly into the bladder compared with a placebo after surgery in treating patients with newly diagnosed or recurrent bladder cancer
Detailed Description:
OBJECTIVES
Primary
Compare the efficacy of a single intravesical instillation of gemcitabine hydrochloride vs placebo immediately after transurethral resection of the bladder tumor TURBT in preventing recurrence at 2 years in patients with grade 1 or 2 superficial transitional cell cancer of the bladder
Secondary
Compare whether a single instillation of intravesical gemcitabine hydrochloride can improve the time to progression to muscle invasive disease vs placebo in these patients
Compare the qualitative and quantitative toxicities of these regimens in these patients
Compare whether treatment with post-TURBT intravesical instillation of gemcitabine vs placebo results in reduced long-term morbidity in patients as defined by requirement for fewer TURBTs courses of traditional intravesical therapies and surveillance cystoscopies over 4 years
Tertiary
Assess whether performing a combination of molecular andor cytologic diagnostic marker tests including NMP-22 Bladder Chek and BTA Stat every 3 months can predict recurrence as accurately as cystoscopy alone in these patients
OUTLINE This is a randomized double-blind multicenter study Patients are stratified according to disease status first occurrence vs recurrent disease and number of tumor sites 1 vs 2 Patients are randomized to 1 of 2 treatment arms
All patients undergo transurethral resection of the bladder tumor Within 3 hours patients receive intravesical therapy according to their randomized arm
Arm I Patients receive intravesical gemcitabine hydrochloride over 1 hour
Arm II Patients receive intravesical placebo over 1 hour Urine is collected at baseline and then every 3 months for 2 years for research studies including the NMP-22 Bladder Chek and BTA Stat test
After completion of study treatment patients are followed every 3 months for 2 years and then every 6 months for 2 years
PROJECTED ACCRUAL A total of 340 patients will be accrued for this study
Primary
Compare the efficacy of a single intravesical instillation of gemcitabine hydrochloride vs placebo immediately after transurethral resection of the bladder tumor TURBT in preventing recurrence at 2 years in patients with grade 1 or 2 superficial transitional cell cancer of the bladder
Secondary
Compare whether a single instillation of intravesical gemcitabine hydrochloride can improve the time to progression to muscle invasive disease vs placebo in these patients
Compare the qualitative and quantitative toxicities of these regimens in these patients
Compare whether treatment with post-TURBT intravesical instillation of gemcitabine vs placebo results in reduced long-term morbidity in patients as defined by requirement for fewer TURBTs courses of traditional intravesical therapies and surveillance cystoscopies over 4 years
Tertiary
Assess whether performing a combination of molecular andor cytologic diagnostic marker tests including NMP-22 Bladder Chek and BTA Stat every 3 months can predict recurrence as accurately as cystoscopy alone in these patients
OUTLINE This is a randomized double-blind multicenter study Patients are stratified according to disease status first occurrence vs recurrent disease and number of tumor sites 1 vs 2 Patients are randomized to 1 of 2 treatment arms
All patients undergo transurethral resection of the bladder tumor Within 3 hours patients receive intravesical therapy according to their randomized arm
Arm I Patients receive intravesical gemcitabine hydrochloride over 1 hour
Arm II Patients receive intravesical placebo over 1 hour Urine is collected at baseline and then every 3 months for 2 years for research studies including the NMP-22 Bladder Chek and BTA Stat test
After completion of study treatment patients are followed every 3 months for 2 years and then every 6 months for 2 years
PROJECTED ACCRUAL A total of 340 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| S0337 | OTHER | None | None |
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |