NCT01104350CompletedPhase 1
Image-Guided Radiation Therapy for Bladder-Cancer Patients Undergoing Radiotherapy and Concurrent Gemcitabine Chemotherapy
Phase I Dose-Escalation Study of Image-Guided Radiation Therapy for Bladder-Cancer Patients Undergoing Radiotherapy and Concurrent Gemcitabine Chemotherapy
Source: ClinicalTrials.gov · Last updated 5 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 19 (actual)
- First submitted
- 14 Apr 2010
- Start date
- Apr 2010
- Primary completion date
- 3 Mar 2026
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Diseases
- Bladder cancer
- NCT number
- NCT01104350
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 19
- From Apr 2010 to the primary completion date, 3 Mar 2026
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous pelvic radiation therapy
- Prior systemic chemotherapy non-cisplatin based neoadjuvant for urothelial carcinoma (prior intravesical chemotherapy or immunotherapy is permissible)
- Prior cisplatin based neoadjuvant systemic chemotherapy for more than \>4 cycles
Other illness
- Evidence of distant disease or histologically-proven nodal metastases. Patients with radiologic evidence of lymphadenopathy must have biopsy proof of N0 status.
- Active inflammatory bowel disease (i.e., Crohn's disease or ulcerative colitis)
Other
- Women who are pregnant or lactating
Who the study is looking for
- MSKCC-reviewed pathologically proven diagnosis of primary bladder urothelial carcinoma without evidence of regional (nodal) or distant spread (cT1-T4a, Nx or N0).
- Karnofsky Performance Scale (KPS) ≥ 70%
- Age ≥18 years old
- Adequately functioning bladder, defined as continent and without the need for an indwelling catheter
- Absolute neutrophil count (ANC) ≥ 1500/mL; platelets ≥ 100,000/mm3 serum bilirubin \< 1.5 x the upper limit of normal (ULN); aspartate aminotransferase (AST) and/alanine aminotransferase (ALT) ≤ 1.5 × ULN
- Adequate renal function: calculated creatinine clearance \> 30 mL/min/1.73 m2 using the following formula modified Cockcroft and Gault Formula for estimated Creatinine Clearance
- Patients must be considered able to tolerate systemic chemotherapy and pelvic radiation therapy.
- Patients must have the ability to understand and the willingness to sign a written informed consent document
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Memorial Sloan Kettering at Basking Ridge Coordinator of this site? Confirm its status | Basking Ridge | United States | Unknown status |
| Memorial Sloan Kettering Cancer Center @ Suffolk Coordinator of this site? Confirm its status | Commack | United States | Unknown status |
| Memorial Sloan Kettering Westchester Coordinator of this site? Confirm its status | Harrison | United States | Unknown status |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Memorial Sloan Kettering at Mercy Medical Center Coordinator of this site? Confirm its status | Rockville Centre | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.