A Phase 1 interventional study of external radiation therapy with gemcitabine in Bladder Cancer, sponsored by Memorial Sloan Kettering Cancer Center. Completed at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-05.
Sponsored by Memorial Sloan Kettering Cancer Center · Phase 1, Interventional, and Treatment
The purpose of this study is to test the safety of different amounts (doses) of external radiation therapy (high-energy x-rays that shrink or destroy cancer) combined with chemotherapy.
1,617 studies on the registry are indexed under Urinary Bladder Neoplasms; 422 are open to participants now.
This study's enrollment of 19 is below the median of 60 across 1,163 interventional studies indexed under Urinary Bladder Neoplasms.
Browse Urinary Bladder Neoplasms studies →Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,930 studies on the registry; 325 are open to participants now.
Of its 129 completed or terminated interventional studies of FDA-regulated products, 66 (51%) have results posted.
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This is a Phase I dose-escalation study examining the safety and tolerability of intensity modulated external radiation therapy using image-guidance in combination with gemcitabine chemotherapy as an alternative to radical cystectomy.
Other: external radiation therapy with gemcitabine
All patients will undergo daily image-guided radiation therapy with concurrent twice weekly gemcitabine chemotherapy. Radiation therapy will begin 2-4 weeks after restaging cystoscopy/fiducial marker placement. * Dose level #1: 23.4 Gy/1.8 Gy × 13 fractions (total dose 68.4 Gy) * Dose level #2: 27.0 Gy/1.8 Gy × 15 fractions (total dose 72.0 Gy) * Dose level #3: 30.6 Gy/1.8 Gy × 17 fractions (total dose 75.6 Gy)
To determine the dose limiting toxicity and establish the maximal tolerated dose
Time frame: 2 years
To determine the complete response rate of the primary tumor
Time frame: 4-6 weeks following consolidation therapy
To determine the long term toxicity
Time frame: 2 years
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Memorial Sloan Kettering Cancer Center