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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
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

Full criteria on ClinicalTrials.gov

Sites (5)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Memorial Sloan Kettering at Basking Ridge
Coordinator of this site? Confirm its status
Basking RidgeUnited StatesUnknown status
Memorial Sloan Kettering Cancer Center @ Suffolk
Coordinator of this site? Confirm its status
CommackUnited StatesUnknown status
Memorial Sloan Kettering Westchester
Coordinator of this site? Confirm its status
HarrisonUnited StatesUnknown status
Memorial Sloan-Kettering Cancer Center
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
Memorial Sloan Kettering at Mercy Medical Center
Coordinator of this site? Confirm its status
Rockville CentreUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.