PP-Gemcitabine & External Beam Radiation-Sarcomas
NCT02046304 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 41
Last updated 2016-04-06
Summary
The goal of this clinical research study is to find the highest safe dose of gemcitabine that can be given with radiotherapy before surgery to treat sarcoma. This study will also look at how well this treatment controls sarcoma.
Conditions
- Sarcoma
Interventions
- DRUG
-
Starting dose: 400 mg/m2 by vein on days 1, 8, 22, 29, 43, and 50.
- RADIATION
-
Radiation Therapy
Radiation therapy dose of 50 Gy in 25 fractions at 2.0 Gy per fraction. Radiotherapy given once daily (Monday through Friday) for 5 weeks.
Sponsors & Collaborators
- collaborator INDUSTRY
-
M.D. Anderson Cancer Center
lead OTHER
Principal Investigators
-
Peter W. Pisters, MD · M.D. Anderson Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2001-12-31
- Primary Completion
- 2015-03-31
- Completion
- 2015-03-31
Countries
- United States
Study Locations
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