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Image-Guided Radiation Therapy for Bladder-Cancer Patients Undergoing Radiotherapy and Concurrent Gemcitabine Chemotherapy

NCT01104350 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2026-03-05

No results posted yet for this study

Summary

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.

Conditions

Interventions

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)

Sponsors & Collaborators

Principal Investigators

  • Marisa Kollmeier, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2026-03-03
Completion
2026-03-03

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01104350 on ClinicalTrials.gov