Phase 3
Completed N=406
S0337, Gemcitabine After Surgery in Treating Patients With Newly Diagnosed or Recurrent Bladder Cancer
Source: ClinicalTrials.gov NCT00445601 ↗Enrolled (actual)
406
Serious AEs
3.5%
Results posted
Apr 2018
Primary outcomePrimary: Disease Recurrence Rate — 27.86; 40 percentage of patients with recurrence — p=0.01
◆ Published Evidence
Highly cited
237citations · ~30 / year
Effect of Intravesical Instillation of Gemcitabine vs Saline Immediately Following Resection of Suspected Low-Grade Non-Muscle-Invasive Bladder Cancer on Tumor Recurrence: SWOG S0337 Randomized Clinical Trial.
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.
Linked Publications (2)
-
Effect of Intravesical Instillation of Gemcitabine vs Saline Immediately Following Resection of Suspected Low-Grade Non-Muscle-Invasive Bladder Cancer on Tumor Recurrence: SWOG S0337 Randomized Clinical Trial.
-
Risk-Based Assessment Of the Impact Of Intravesical Therapy on Recurrence-Free Survival Rate Following Resection of Suspected Low-grade, Non-muscle-invasive Bladder Cancer (NMIBC): A Southwest Oncology Groups (SWOG) S0337 Posthoc Analysis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Disease Recurrence Rate |
27.86; 40 | 0.01 sig |
| SECONDARY Rate of Progression to Muscle Invasive Disease at 4 Years |
2.49; 4.39 | 0.23 |
| SECONDARY Compare Qualitative and Quantitative Toxicities Between the Treatment Arms |
0; 1; 1; 0; 2; 1 | — |
| SECONDARY Rate of Disease Worsening Over 2 Years |
— | — |
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of newly diagnosed or recurrent transitional cell bladder cancer meeting the following criteria:
- Ta or T1 primary tumor
- Grade 1 or 2 disease
- No more than 2 recurrences (except for index tumor) within the 18 months prior to the index tumor's transurethral resection of the bladder tumor (TURBT)
- Index tumor post-TURBT must meet the following criteria:
- Ta or T1 tumor without any prior tumor in situ, grade 3 (high grade) disease within 2 years prior to index tumor TURBT, or invasion of the muscularis propria (stage ≥ T2)
- Grade 1 or 2 disease (similar to papillary urothelial neoplasm of low malignant potential and low-grade bladder cancer)
- Not a candidate for a therapy other than TURBT (e.g., a series of instillations of intravesical immunotherapy [e.g., BCG] or intravesical chemotherapy, or cystectomy or partial cystectomy)
- Negative upper tract imaging studies within 1 year (365 days) prior to study entry
- Imaging studies may be performed after registration provided it is done prior to TURBT on the day of treatment
- No urothelial cancer of the prostate or more distal urethra (or urethra at all in women) as assessed by endoscopy
- Must have a negative urine culture (less than or equal to 10,000 col/mL, mixed flora-likely contamination) OR negative urine analysis for infection AND negative nitrates on reagent strip, ≤ 10 white blood cell count (WBC)/high-power field, and no rods or organisms on examination of spun urine sediment OR an automated or visual reagent strip urinalysis that is negative for leukocytes and nitrates within the past 28 days
- TURBT planned within the next 28 days and planned treatment within 3 hours after TURBT
PATIENT CHARACTERISTICS:
- Zubrod performance status 0-1
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No other prior malignancy except for any of the following:
- Adequately treated basal cell or squamous cell skin cancer
- In situ cervical cancer
- Adequately treated stage I or II cancer from which patient is in complete remission
- Any other cancer from which patient has been disease-free for 3 years
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- More than 145 days since prior intravesical therapy
Data sourced from ClinicalTrials.gov (NCT00445601) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.