CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 77 enrolled
Drug / intervention
carboplatin +3 moredrug
Likely dose
Gemcitabine, paclitaxel, and carboplatin (specific doses not stated in published record)AI-extracted
Key inclusion· 7
  • ✓Histologically confirmed muscle-invasive (T2-T4a), node-negative (N0) urothelial transitional cell carcinoma of the bladder
  • ✓Focal squamous and/or adenocarcinoma differentiation allowed if ≤10% of tumor volume
  • ✓Initial transurethral resection of bladder tumor (TURBT) and a second TURBT performed within 8 weeks of first
  • ✓Enrollment 14-56 days after second TURBT
Key exclusion· 6
  • ✕Small cell carcinoma or sarcomatoid components
  • ✕Prior systemic chemotherapy for urothelial cancer
  • ✕Prior radiotherapy for urothelial cancer
  • ✕Medical conditions that would preclude radical cystectomy or study compliance

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00045630
NCT00045630Phase 2Completed
CompareCT.gov

A Sequential Approach to the Treatment of Muscle Invasive, Non-Metastatic Urothelial Carcinoma of the Bladder: A Phase II Trial of Neoadjuvant Gemcitabine, Paclitaxel and Carboplatin With Molecular Correlates

SWOG Cancer Research Network·interventional·Posted Jan 27, 2003·Updated May 27, 2013

In Brief

A Phase 2 clinical trial evaluating carboplatin, gemcitabine, and 2 other interventions for Bladder Cancer and 2 related conditions. Completed, enrolled 77 participants across 128 sites.

Detailed Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells and decrease the need for surgery. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by observation or surgery to remove the bladder (cystectomy) in treating patients who have stage II or stage III cancer of the urothelium.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBladder Cancer, Transitional Cell Cancer of the Renal Pelvis and Ureter, Urethral Cancer
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2003
Enrollment StartJan 1, 2003
Primary CompletionMay 1, 2008
Study CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 23.4 years ago

Interventions

carboplatindrug

gemcitabinedrug

paclitaxeldrug

surgeryprocedure